Showing posts with label INX-189. Show all posts
Showing posts with label INX-189. Show all posts
Thursday, August 23, 2012
BMS formally suspends development of BMS-094...
Posted 8/23/2012 on Fox Business.com. BMS formally suspends development of nucleoside inhibitor BMS-094/INX-189 due to possible heart and kidney toxicity. One subject died, nine were hospitalized and two remain so at the time of press. The cause of the events has not yet been identified. Ramifications have already been felt through the HCV drug development space, with Idenix's IDX184 clinical trial, a nucleoside inhibitor similar in structure to BMS-094, put on partial clinical hold by the FDA. The FDA hinted in it's letter to Idenix that there were possibilities of similar actions to other nucs in development as well.
Bristol-Myers Discontinues Development of Hepatitis C Drug
Published August 23, 2012
Dow Jones Newswires
Bristol-Myers Squibb Co. (BMY) said Thursday it has discontinued the development of a drug intended to treat the liver disease hepatitis C in the interest of patient safety, after a patient died and others were hospitalized.
Bristol-Myers earlier this month voluntarily suspended a Phase 2 study of BMS-986094, which was formerly known as INX-189, a nucleotide polymerase inhibitor, or "nuke." The initial case of heart failure, which was the basis for halting the study, subsequently resulted in death, the company said Thursday.
Bristol-Myers said it is working with the U.S. Food and Drug Administration and clinical study investigators to conduct ongoing and close follow-ups of all the study's patients. To date, nine patients have been hospitalized, including the initial patient, and two remain hospitalized.
The company said the cause of these unexpected events, which involve heart and kidney toxicity, hasn't been definitively established.
Bristol-Myers decision to halt the study earlier this month raised questions about the experimental drug's potential and the $2.5 billion price tag Bristol paid earlier this year to buy the company that developed it. The suspension was considered a significant setback for the drug maker--already grappling with weak sales of its Plavix anticlotting drug that lost patent protection in May--in the race to develop new hepatitis C treatments.
Bristol-Myers as well as other companies such as Gilead Sciences Inc. (GILD) and Abbott Laboratories (ABT) has been looking to bring the first all-oral hepatitis C regimen to market, hoping to tap what is expected to be a multibillion-dollar market for such a therapy.
To strengthen its hepatitis C position, Bristol-Myers in February shelled out $2.5 billion to buy Inhibitex Inc. at a whopping 163% premium. Bristol was lured primarily by Inhibitex's nuke for hepatitis C, though it did acquire other potential treatments for infectious disease in the deal.
Treatments for hepatitis C are considered lucrative because the disease is prevalent in large sections of the global population. The virus, which can be transmitted sexually or through use of shared needles and at tattoo parlors, affects some 170 million people world-wide.
Separately, Synergy Pharmaceuticals Inc. (SGYP) said it has agreed to acquire the assets related to shingles treatment FV-100 from Bristol-Myers. FV-100 was developed by Inhibitex.
Shares were up by 10 cents to $32.25 after hours. The stock has fallen 8.8% since the start of the year.
-Write to Nathalie Tadena at nathalie.tadena@dowjones.com
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Monday, May 7, 2012
The Street.com: Bristol-Myers Missing Hep C Data Raises Red Flags, May Boost Gilead, Idenix
Posted on 5/7/12 on The Street.com. The Street.com's Nathan Sadeghi-Nejad is picking up some signals that BMS might be having trouble with his polymerase inhibitor INX-189 (now BMS-094) acquisition from Inhibitex. Namely, Sadeghi-Nejad points to a chemical called 1-naphthol that is a byproduct of in the metalbolization of BMS-094 that is toxic to hepatocytes. Details below.
Bristol-Myers Missing Hep C Data Raises Red Flags, May Boost Gilead, Idenix
Nathan Sadeghi-Nejad
05/07/12 - 07:00 AM EDT
NEW YORK (TheStreet) -- Since my return from the European Association for the Study of the Liver (EASL) conference two weeks ago, I have been unable to get over the strange behavior of executives at Bristol-Myers Squibb(BMY). As I discussed in my EASL wrap-up, investors should view with suspicion Bristol-Myers' complaints about Gilead Sciences'(GILD) refusing to collaborate on a late-stage study of the hepatitis C drugs GS-7977 and daclatasvir partnership. Then there's Bristol-Myers' odd and prolonged silence about INX-189 -- the nucleoside polymerase inhibitor, or "nuc," acquired in the $2.5 billion Inhibitex deal.
I suspect something is wrong with Bristol-Myers' INX-189, which has since been renamed by the company as BMS-094. The red flags are popping up everywhere. If I'm right about Bristol-Myers being in trouble, Gilead's lead in the race to develop all oral therapies for hepatitis C will expand and Idenix Pharmaceuticals'(IDIX) hepatitis C drugs become more attractive.
Let's examine the details:
1. New BMS-094 data should have been available by EASL. In mid-January, Bristol-Myers completed enrollment in a Phase II trial of BMS-094 in genotype 2/3 patients, an easier-to-treat subpopulation of hepatitis C. By the time the hepatitis C world gathered in Barcelona for EASL in April, Bristol-Myers likely had four-week and 12-week on-treatment viral response data from this study. These results will provide an important first look at BMS-094's efficacy and safety, yet Bristol-Myers said nothing about the data at EASL.
2. Bristol-Myers passed on a second chance to provide insight on BMS-094 during the company's first-quarter earnings conference call. At least 16 weeks have now passed since the study completed enrollment. By now, Bristol-Myers should have four-week sustained virologic response (SVR4) data, an early indication of cure.
Yet on its April 26 conference call, Bristol-Myers executives once again declined to provide a meaningful clinical update on BMS-094. Instead, Chief Scientific Officer Elliot Sigal spoke in generalities about the drug.
"We feel that there are multiple doses that are safe for human testing from 50 to 200 [mg]," said Sigal , referring to BMS-094. "We will be getting more experience with 200 [mg] throughout this year. We will have safety data on a range of doses of 50 to 100 [mg], which we will at least have internally and hopefully talk about towards the end of the year." [Emphasis mine.]
3. BMS-094 produces a toxic metabolite. At a scientific conference in 2010, Inhibitex presented preclinical data on the metabolic pathway for BMS-094, then known as INX-189. The first step in this metabolic pathway yields a byproduct called 1-naphthol, a chemical that is toxic to hepatocytes, or liver cells. (My source for the background data is a 1984 paper published in Biochemical Pharmacology.) To be fair, the clinical importance of 1-naphthol at BMS-094's potential clinical doses remains unclear. However, two other nucs in clinical development -- Gilead's GS-7977 and Idenix' IDX-184 -- do not produce 1-naphthol. As an investor, the presence of this toxic byproduct should be a big concern until proven otherwise.
4. BMS-094 has shown potential toxicity across multiple organ systems. Data presented in 2009 indicate that BMS-094 (again, known then as INX-189) has a relatively low CC50, a measure of cytotoxicity, across lymphoid, bone marrow, kidney, and liver cells. Bulls will, reasonably, counter by citing the drug's potency and resulting therapeutic index, an indicator of drug safety equivalent to the ratio of the drug's in vitro efficacy measured via the EC50 relative to CC50. For BMS-094, the
therapeutic index is widest in lymphoid tissue and narrowest in the bone marrow, with liver in the middle. Again, this single data point isn't a smoking gun, but it does raise another red flag.
5. BMS-094 appears far less effective at lower doses than Gilead's GS-7977. After three days of dosing at 200 mg once daily, BMS-094 reduces median viral load by roughly 3.0 log. That's less than the 3.7 log viral load reduction seen with a 400 mg once-daily dose of Gilead's GS-7977 after three days, although in the same ballpark and therefore comparable and competitive.
At a 100 mg once-daily dose, however, BMS-094's impact is far less impressive, with a 1.15 log reduction in viral load. This brings BMS-094's effect size closer to Idenix's nuc IDX-184, which gets criticized for lackluster efficacy. [I think the jury is still out on the Idenix nuc. Management claims the drug's effect size will improve over time. That's possible, since BMS-094 gains some efficacy with an additional few days of dosing.]
If Bristol-Myers can't dose BMS-094 safely at 200 mg, the drug may not be competitive with Gilead's GS-7977. (Gilead's GS-7977 studies use a 400 mg once daily dose.) Importantly, none of Bristol-Myers' ongoing or publicly listed BMS-094 studies use the 200 mg once-daily dose. Not a good sign.
6. Bristol-Myers had limited safety data for BMS-094 when it purchased Inhibitex. Investors frequently cite a partnership or acquisition as validation of the smaller company's technology. I often disagree with the validation hypothesis, and that's true in this case. It seems very unlikely that Bristol-Myers had meaningful non-public safety data for BMS-094 prior to the company's January purchase of Inhibitex for $2.5 billion. This limited visibility might not raise a red flag, but I think it makes the validation defense less compelling.
Bristol-Myers is a big company so the investment impact of potential trouble in its hepatitis C drug pipeline is unclear. Most analyst models don't yet include forecasts for significant sales from the company's experimental hepatitis C drugs. The anticoagulant Eliquis, which has an FDA approval decision date in late June, is by far Bristol-Myers' most important near-term driver. [I expect Eliquis to receive approval, and consensus earnings estimates look achievable but not necessarily low.]
Nonetheless, failure of a high-profile program like BMS-094 would certainly knock the shine off Bristol-Myers' 17-timesearnings multiple, which exceeds most of the company's peer group. I think it's worth considering Bristol-Myers as a short, butI wouldn't make it a big position.
Failure or problems with Bristol-Myers' nuc would likely have a more significant impact on Gilead and, potentially, Idenix. Bothcompanies stand to benefit should BMS-094 stumble. Idenix would have a more attractive asset in IDX-184. I think it's worth taking a small long position in Idenix at current prices.
I think Gilead has more to gain from possible Bristol-Myers problems. Gilead would expand its lead in the race to develop an all oral regimen for HCV, and would gain significant negotiating leverage in any development partnership discussions. Given the potential for multiple positive catalysts over the next year -- including likely FDA approval of the Quad HIV pill this summer -- I am inclined to be long Gilead. I would not be an aggressive buyer of the stock until or unless it dips meaningfully below
$50 per share.
Disclosure: Sadeghi has no positions in any of the stocks mentioned in this article
Monday, February 13, 2012
BMS completes tender offer for Inhibitex Inc...
Bristol-Myers completes Inhibitex tender offer
TRENTON, N.J. (AP) — Bristol-Myers Squibb Co. said Monday that it's completed its tender offer for the stock of Inhibitex Inc., a drug developer that Bristol is buying for $2.5 billion as part of its strategy to become a player in the hot hepatitis C drug market.
New York-based Bristol-Myers said it now has about 91 percent of outstanding shares of Inhibitex, after buying just over 77.5 million shares through midnight Friday for $26 each.
That's the last step before the merger can be executed. A Bristol-Myers spokeswoman on Monday said the company is working to quickly complete the deal but could not say when it will close.
When that happens, remaining Inhibitex shares will be canceled, their owners will be able to receive $26 per share and Inhibitex will become a wholly owned subsidiary of Bristol-Myers.
Earlier in February, the federal antitrust review period under the Hart-Scott-Rodino Antitrust act expired, satisfying a key condition of the offer.
Bristol-Myers is an important maker of medicines for viruses, including Baraclude for hepatitis B and several HIV drugs, but has nothing for hepatitis C at a time when more patients need treatment. Over 3 million Americans have the blood-borne, tough-to-treat disease, which can go undetected for many years until the liver is severely damaged. More people will be diagnosed as the baby boomer generation ages.
After a two-decade drought, the first two new hepatitis C drugs were approved last year: Victrelis from Merck & Co. and Incivek, marketed by partners Vertex Pharmaceuticals Inc. and Johnson & Johnson. Both significantly improve the cure rate over what has long been the standard of care — a mix of injections and pills with nasty, flu-like side effects that takes several months and still doesn't cure many patients.
Last month, Bristol-Myers CEO Lamberto Andreotti said his company has four experimental hepatitis C drugs in development that could be a big improvement over the pills-and-shots regimen. The Bristol compounds might also be combined with those of Inhibitex to produce an even more-effective treatment.
Inhibitex has three experimental drugs in midstage human testing, including INX-189, for treating chronic hepatitis C infections. The other two compounds are FV-100, for reducing the pain caused by shingles, and Aurexis, a biologic antibody-based drugs for treating dangerous staph infections in the blood.
Inhibitex also has other potential hepatitis C treatments in laboratory testing, and has a proprietary technology that it's licensed to Pfizer Inc. for developing a possible staph vaccine.
Thursday, December 1, 2011
The Motley Fool's Sean Williams on Inhibitex....
Inhibitex Shares Popped: What You Need to Know
By Sean Williams
December 1, 2011
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Inhibitex, one of many biotechnology companies involved in hepatitis C research, jumped as much as 13% earlier in the trading session before giving up almost all of its gains.
So what: Ever since Gilead Sciences agreed to purchase Pharmasset last week at a hefty premium, the sector has been abuzz with more buyout speculation. Optimists got more fuel for the fire earlier in the week when Inhibitex reported positive phase 2 results for INX-189, its experimental hepatitis C drug. Today's move appears to be a carryover effect of the bullishness from previous days.
Now what: To say that I'm not a fan of Inhibitex at its current valuation north of $1.1 billion might be an understatement. The company is going to face an onslaught of competition from Gilead and Pharmasset, but also from hep C drugs that are already approved by the FDA for sale, including Merck's Victrelis and Vertex Pharmaceuticals' Incivek. Then there's the fact that Inihibtex has already sold 1.9 million shares of stock into this unbelievable rally. With its leading drug candidate only in phase 2 clinical trials, there are plenty of moves left to be played in this chess game before I'd declare Inhibitex a winner. I'm so confident Inhibitex is overvalued at these levels I'm willing to bet my CAPS points on it!
By Sean Williams
December 1, 2011
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Inhibitex, one of many biotechnology companies involved in hepatitis C research, jumped as much as 13% earlier in the trading session before giving up almost all of its gains.
So what: Ever since Gilead Sciences agreed to purchase Pharmasset last week at a hefty premium, the sector has been abuzz with more buyout speculation. Optimists got more fuel for the fire earlier in the week when Inhibitex reported positive phase 2 results for INX-189, its experimental hepatitis C drug. Today's move appears to be a carryover effect of the bullishness from previous days.
Now what: To say that I'm not a fan of Inhibitex at its current valuation north of $1.1 billion might be an understatement. The company is going to face an onslaught of competition from Gilead and Pharmasset, but also from hep C drugs that are already approved by the FDA for sale, including Merck's Victrelis and Vertex Pharmaceuticals' Incivek. Then there's the fact that Inihibtex has already sold 1.9 million shares of stock into this unbelievable rally. With its leading drug candidate only in phase 2 clinical trials, there are plenty of moves left to be played in this chess game before I'd declare Inhibitex a winner. I'm so confident Inhibitex is overvalued at these levels I'm willing to bet my CAPS points on it!
Monday, September 19, 2011
Inhibitex starts dosing in Phase II trial looking at INX-189 in HCV genotype 2 & 3 subjects...
Inhibitex Commences Dosing of Phase 2 Clinical Trial of INX-189 in HCV Infected Genotype 2/3 Patients
Phase 1b Extension Trial in HCV-Infected Genotype 1 Patients to Evaluate Higher Doses of INX-189 Also Initiated
ATLANTA, Sep 19, 2011 (BUSINESS WIRE) -- Inhibitex, Inc. INHX +2.13% , announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naive patients. The trial is designed to evaluate three once-daily doses of INX-189 (25 mg, 50 mg and 100 mg) administered in combination with pegylated interferon and ribavirin for 12 weeks, and also includes a control arm in which patients will receive placebo and standard of care treatment (a combination of pegylated interferon and ribavirin for 24 weeks). Each INX-189 combination treatment cohort in the trial will include 25 patients, and the control arm will include 15 patients.
Patients in the INX-189 containing treatment arms that achieve an extended rapid viral response, or eRVR, defined as having HCV RNA below the level of detection after 28 days and 12 weeks of dosing, will stop all therapy after 12 weeks. Those patients who do not achieve an eRVR will continue receiving pegylated interferon and ribavirin for 12 additional weeks.
The Company also announced the initiation of an additional clinical trial of INX-189 designed to evaluate higher doses of INX-189 administered as monotherapy or in combination with ribavirin for seven days. The first cohort in this expanded Phase 1b trial will receive 200 mg INX-189 once daily as monotherapy. Other planned cohorts include 100 mg INX-189 twice daily as monotherapy, 100 mg INX-189 once daily in combination with ribavirin, and possibly higher monotherapy doses of INX-189. Each treatment cohort in the trial will include 10 patients, eight of which will receive INX-189 and two of which will receive placebo.
About HCV and INX-189
Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2'-C-methyl guanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's clinical-stage pipeline currently includes two Phase 2 development programs; INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit www.inhibitex.com .
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the number of patients the Company expects to enroll in the ongoing Phase 2 trial and the planned cohorts, and possibly including higher monotherapy doses of INX-189, in the ongoing supplementary Phase 1b trial, and the Company's belief that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of the Company, the FDA, a data safety monitoring board, an institutional review board (IRB), delaying, limiting, suspending or terminating the clinical development of INX-189 at any time for a lack of safety, tolerability, biologic activity or efficacy, commercial viability, regulatory issues, or any other reason and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2010 and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2011. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex(R) and MSCRAMM(R) are registered trademarks of Inhibitex, Inc.
SOURCE: Inhibitex, Inc.
Inhibitex
Russell H. Plumb, 678-746-1136
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, 646-378-2922
CFA
lstern@troutgroup.com
Phase 1b Extension Trial in HCV-Infected Genotype 1 Patients to Evaluate Higher Doses of INX-189 Also Initiated
ATLANTA, Sep 19, 2011 (BUSINESS WIRE) -- Inhibitex, Inc. INHX +2.13% , announced today that it has recently commenced dosing in a 90-patient randomized, placebo controlled, treatment guided, Phase 2 clinical trial to evaluate the safety, tolerability and antiviral activity of INX-189 in combination with pegylated interferon and ribavirin in chronic HCV-infected genotype 2 and 3 treatment naive patients. The trial is designed to evaluate three once-daily doses of INX-189 (25 mg, 50 mg and 100 mg) administered in combination with pegylated interferon and ribavirin for 12 weeks, and also includes a control arm in which patients will receive placebo and standard of care treatment (a combination of pegylated interferon and ribavirin for 24 weeks). Each INX-189 combination treatment cohort in the trial will include 25 patients, and the control arm will include 15 patients.
Patients in the INX-189 containing treatment arms that achieve an extended rapid viral response, or eRVR, defined as having HCV RNA below the level of detection after 28 days and 12 weeks of dosing, will stop all therapy after 12 weeks. Those patients who do not achieve an eRVR will continue receiving pegylated interferon and ribavirin for 12 additional weeks.
The Company also announced the initiation of an additional clinical trial of INX-189 designed to evaluate higher doses of INX-189 administered as monotherapy or in combination with ribavirin for seven days. The first cohort in this expanded Phase 1b trial will receive 200 mg INX-189 once daily as monotherapy. Other planned cohorts include 100 mg INX-189 twice daily as monotherapy, 100 mg INX-189 once daily in combination with ribavirin, and possibly higher monotherapy doses of INX-189. Each treatment cohort in the trial will include 10 patients, eight of which will receive INX-189 and two of which will receive placebo.
About HCV and INX-189
Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2'-C-methyl guanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's clinical-stage pipeline currently includes two Phase 2 development programs; INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit www.inhibitex.com .
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the number of patients the Company expects to enroll in the ongoing Phase 2 trial and the planned cohorts, and possibly including higher monotherapy doses of INX-189, in the ongoing supplementary Phase 1b trial, and the Company's belief that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV, are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of the Company, the FDA, a data safety monitoring board, an institutional review board (IRB), delaying, limiting, suspending or terminating the clinical development of INX-189 at any time for a lack of safety, tolerability, biologic activity or efficacy, commercial viability, regulatory issues, or any other reason and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2010 and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2011. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex(R) and MSCRAMM(R) are registered trademarks of Inhibitex, Inc.
SOURCE: Inhibitex, Inc.
Inhibitex
Russell H. Plumb, 678-746-1136
Chief Executive Officer
rplumb@inhibitex.com
or
The Trout Group
Lee M. Stern, 646-378-2922
CFA
lstern@troutgroup.com
Thursday, August 25, 2011
Baird analyst rates Inhibitex stock "outperform" based on HCV polymerase inhibitor INX-189...
Associated Press
Ahead of the Bell: Inhibitex rates 'outperform'
By The Associated Press, 08.25.11, 09:23 AM EDT
Inhibitex has a promising potential treatment for the Hepatitis C virus, according to a Baird analyst who started coverage of the biotechnology company with an "outperform" rating.
Thomas J. Russo said in a Thursday morning research note the Alpharetta, Ga., company's molecule labeled INX-189 is a "real value driver" in an important class of treatments. INX-189 is a potential Hepatitis C treatment called a nucleotide polymerase inhibitor in mid-stage drug development. The analyst said these drugs have a "scarcity value" and that compound appears "very much in the game."
Inhibitex ( INHX - news - people ) Inc. does not have any products on the market, and most of its revenue comes from collaborations. It focuses on developing treatments for viral infections, and it also has a potential shingles treatment in late-stage testing.
Hepatitis C is the primary cause of liver transplants in the U.S. and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. The disease could also be picked up from blood transfusions before 1992, when testing of the blood supply for the virus began.
Ahead of the Bell: Inhibitex rates 'outperform'
By The Associated Press, 08.25.11, 09:23 AM EDT
Inhibitex has a promising potential treatment for the Hepatitis C virus, according to a Baird analyst who started coverage of the biotechnology company with an "outperform" rating.
Thomas J. Russo said in a Thursday morning research note the Alpharetta, Ga., company's molecule labeled INX-189 is a "real value driver" in an important class of treatments. INX-189 is a potential Hepatitis C treatment called a nucleotide polymerase inhibitor in mid-stage drug development. The analyst said these drugs have a "scarcity value" and that compound appears "very much in the game."
Inhibitex ( INHX - news - people ) Inc. does not have any products on the market, and most of its revenue comes from collaborations. It focuses on developing treatments for viral infections, and it also has a potential shingles treatment in late-stage testing.
Hepatitis C is the primary cause of liver transplants in the U.S. and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. The disease could also be picked up from blood transfusions before 1992, when testing of the blood supply for the virus began.
Sunday, January 9, 2011
Inhibitex bullish on it's Phase 1b safety and antiviral data for INX-189....
Phase 1b data for nuc INX-189. Monotherapy doses with 25 mg are good for a log drop in VL after 7 days, minimal adverse events and QD dosing. Inhibitex is gearing up for more early phase monotherapy trials, as well as trials with ribavirin. Nothing mentioned about peg-interferon... interesting.
Released: 01/09/11 06:00 PM EST
Inhibitex, Inc. (Nasdaq: INHX) today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV).
The trial, which is being conducted under an IND in the United States, is a double-blind, placebo-controlled, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of INX-189, administered orally once-daily for seven days, for the treatment of HCV genotype 1 treatment naïve patients. Each treatment cohort in the study is comprised of 10 patients, eight that receive INX-189 and two that receive placebo. In addition to the 9 mg and 25 mg dose cohorts, the Company plans to enroll up to three more INX-189 monotherapy cohorts in the study, as well as two cohorts that will receive different doses of INX-189 once daily for seven days in combination with ribavirin.
INX-189, dosed once-daily at 9mg and 25mg for seven days, demonstrated potent antiviral activity with a mean HCV RNA reduction from baseline levels of -0.71 and -1.03 log10 IU/mL, respectively. The mean HCV RNA decline from baseline levels observed in patients that received placebo was -0.06 log10 IU/mL. The HCV RNA declines from baseline were statistically significant from placebo, with p-values of 0.0156 and 0.0006 in the 9 mg and 25 mg cohorts, respectively. In addition to the mean reductions in viral load, clinically meaningful decreases in alanine transaminase (ALT) levels were observed for patients receiving INX-189 at both dose levels and no patients experienced viral breakthrough.
Preliminary assessments of the data available from the first two cohorts in the Phase 1b study indicate that INX-189 was well tolerated. There were no serious adverse events reported, no discontinuations due to an adverse event, and no adverse events related to changes in clinical laboratory evaluations. All reported adverse events were mild or moderate and were not dose dependent. In addition, the pharmacokinetics of the 9mg and 25mg doses in HCV-infected patients were comparable to those observed in healthy volunteers, and continue to support the evaluation of INX-189 as a once-daily therapy.
“We are pleased with the interim results of the trial to-date and the rapid and potent antiviral activity demonstrated at these low doses of INX-189,” commented Joseph M. Patti, Ph.D., Inhibitex’s CSO and Senior Vice-President of Research. “We look forward to completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in this ongoing study, and anticipate reporting additional safety, antiviral and pharmacokinetic data from the study upon its completion later this quarter.”
About HCV and INX-189
Hepatitis C is a disease of the liver caused by HCV. It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methylguanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
In a Phase 1a study, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial demonstrated the following:
* INX-189 was well tolerated at all dose levels;
* No drug-related serious adverse events;
* No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache, nasal congestion, ecchymosis, and presyncope;
* No grade II or higher laboratory abnormality adverse events; and
* Pharmacokinetic data supported INX-189’s potential for once-daily dosing.
Released: 01/09/11 06:00 PM EST
Inhibitex, Inc. (Nasdaq: INHX) today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV).
The trial, which is being conducted under an IND in the United States, is a double-blind, placebo-controlled, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of INX-189, administered orally once-daily for seven days, for the treatment of HCV genotype 1 treatment naïve patients. Each treatment cohort in the study is comprised of 10 patients, eight that receive INX-189 and two that receive placebo. In addition to the 9 mg and 25 mg dose cohorts, the Company plans to enroll up to three more INX-189 monotherapy cohorts in the study, as well as two cohorts that will receive different doses of INX-189 once daily for seven days in combination with ribavirin.
INX-189, dosed once-daily at 9mg and 25mg for seven days, demonstrated potent antiviral activity with a mean HCV RNA reduction from baseline levels of -0.71 and -1.03 log10 IU/mL, respectively. The mean HCV RNA decline from baseline levels observed in patients that received placebo was -0.06 log10 IU/mL. The HCV RNA declines from baseline were statistically significant from placebo, with p-values of 0.0156 and 0.0006 in the 9 mg and 25 mg cohorts, respectively. In addition to the mean reductions in viral load, clinically meaningful decreases in alanine transaminase (ALT) levels were observed for patients receiving INX-189 at both dose levels and no patients experienced viral breakthrough.
Preliminary assessments of the data available from the first two cohorts in the Phase 1b study indicate that INX-189 was well tolerated. There were no serious adverse events reported, no discontinuations due to an adverse event, and no adverse events related to changes in clinical laboratory evaluations. All reported adverse events were mild or moderate and were not dose dependent. In addition, the pharmacokinetics of the 9mg and 25mg doses in HCV-infected patients were comparable to those observed in healthy volunteers, and continue to support the evaluation of INX-189 as a once-daily therapy.
“We are pleased with the interim results of the trial to-date and the rapid and potent antiviral activity demonstrated at these low doses of INX-189,” commented Joseph M. Patti, Ph.D., Inhibitex’s CSO and Senior Vice-President of Research. “We look forward to completing the remaining monotherapy cohorts and evaluating the potential antiviral synergies of INX-189 in combination with ribavirin in this ongoing study, and anticipate reporting additional safety, antiviral and pharmacokinetic data from the study upon its completion later this quarter.”
About HCV and INX-189
Hepatitis C is a disease of the liver caused by HCV. It is estimated that over 4 million Americans and 170 million individuals worldwide are infected with HCV, the majority of which represent chronic infections that can cause liver disease, cirrhosis and cancer, and is the leading cause of liver transplants in the United States.
Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. INX-189 is a protide of a 2’-C-methylguanosine analogue. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily oral therapy amenable to combination with other antivirals for the treatment of patients with all known genotypes of HCV.
In a Phase 1a study, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial demonstrated the following:
* INX-189 was well tolerated at all dose levels;
* No drug-related serious adverse events;
* No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache, nasal congestion, ecchymosis, and presyncope;
* No grade II or higher laboratory abnormality adverse events; and
* Pharmacokinetic data supported INX-189’s potential for once-daily dosing.
Wednesday, September 1, 2010
Inhibitex completes phase 1a trial of nucleotide polymerase inhibitor INX-189
Proof-of-Concept Trial in Patients with Chronic Hepatitis C Planned for Q4 2010
- INX-189 was generally well tolerated at all dose levels;
- No drug-related serious adverse events;
- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
- Pharmacokinetic data supports INX-189's potential for once daily (QD) dosing.
“We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial,” stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. “Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter.”
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's pipeline includes FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.
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