Initial Abbott Labs interferon-free triple combination data released...

Posted 10/15/12 on Trust.org. The pre-AASLD press release parade is in full swing!! This time Abbott Labs checks in with some pretty impressive data (although you never know until you see the full abstract/presentation) with it's 3 drug interferon-free combo + ribavirin (HCV protease inhibitor ABT-450, polymerase inhibitor ABT-333 and NS5A inhibitor ABT-267 + RBV).  Although the numbers are small, 76 out of 77 treatment naive patients and 38 out of 41 null responders achieved SVR12. I believe, however, it was an Abbott's PILOT study looking at a combo of ABT-450 plus non-nuc ABT-072 and RBV where two patients experienced 'late relapse'... one at week 8 post-treatment and one at week 36. We'll have to see if 'late relapse' is a phenomena with just that certain combination or if a more robust 3 drug combination is enough to quash the virus for a true SVR.  I'd also like to see the IL28B genotype and sub-type of this study population, as well as BMI, steatosis and cirrhosis percentages as well. But without the benefit of an in-depth look under the hood,  this initial data looks pretty impressive. 

Mon, 15 Oct 2012 18:27 GMT
Source: Reuters // Reuters

* 99 pct of untreated patients achieve cure, or SVR, at 12 weeks

* 93 pct of previously unresponsive patients reach SVR at 12 weeks

* Abbott shares rise 3.3 percent (Adds analyst comment, updates shares)

By Bill Berkrot

Oct 15 (Reuters) - An all oral regimen of experimental hepatitis C medicines developed by Abbott Laboratories led to high cure rates in both new patients and those for whom prior treatment failed, according to initial results from a midstage study.

Shares of Abbott rose more than 3 percent after the unveiling of the data, which will be presented next month at a major liver disease meeting. The findings should help cement Abbott as a major player in the race to develop an interferon-free treatment regimen for the serious liver disease.

After 12 weeks of treatment with three Abbott direct-acting antiviral medicines plus the older drug ribavirin, 99 percent of previously untreated patients and 93 percent of those who did not respond to older drugs achieved a sustained virologic response (SVR), which is considered cured, according to available data from a brief summary, or abstract, of the study.

Abbott will present much more detail on the Phase II study involving data from more patients at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston.

"The data looks very good on efficacy and I didn't see anything that really caught my eye as far as side effects," Morningstar analyst Damien Conover said.

Based on the results, Abbott said it would test its three drugs, each of which attacks the virus using a different approach, both with and without ribavirin in a large Phase III program aimed at gaining approval for the treatment.

"The ability to show a sustained virological response in these patient populations without the use of interferon is extremely encouraging," Scott Brun, Abbott's head of infectious disease development, said in a statement.

A pair of new hepatitis C drugs approved last year significantly boosted cure rates and cut treatment duration to as low as 24 weeks for some patients. But those must still be taken with interferon, an injected drug that often causes severe flu-like symptoms that lead many hepatitis patients to delay or discontinue treatment.

Several companies, including Gilead Sciences Inc, Bristol-Myers Squibb Co and Vertex Pharmaceuticals Inc , are racing to develop interferon-free treatment regimens expected to bring in billions of dollars in revenue once approved.

Most analysts view Gilead as current leader both on timing and perceived advantages of its experimental hepatitis C program.

"One of the questions lingering here is whether these (Abbott) drugs can be used without ribavirin," Conover said. "Gilead's drug works pretty well without it, so it's going to be a pretty big competitive hurdle if they have to use ribavirin."

While not as onerous as interferon, ribavirin also has side effects that doctors and patients would like to avoid if possible.

The Abbott drugs, a protease inhibitor called ABT-450, a polymerase inhibitor ABT-333 and ABT-267 from a class known as NS5A inhibitors, were given along with ribavirin for just 12 weeks. Patients in whom the virus was undetectable 12 weeks after stopping treatment were considered cured.

Based on available data at the time the abstract was submitted for the liver meeting, 76 of 77 previously untreated patients and 38 of 41 prior null responders had achieved SVR.

Null responders, while a much smaller market than new patients, have been notoriously difficult to treat.

"The data presented so far appear to be very favorable in these early trials and we'll look for more extensive data at AASLD," JP Morgan analyst Michael Weinstein said in a research note, adding that he expects Abbott's hepatitis C program to reach the market by 2015.

One subject in the new patient group had a disease relapse after treatment and three of the prior null responders experienced viral breakthrough, meaning the virus levels rose during treatment after an initial response.

The most common side effects were fatigue and headache in both groups. Of five reported serious adverse events, one - joint pain - was deemed to be possibly caused by study drugs, the company said.

Abbott shares were up $2.29, or 3.3 percent, at $71.57 at midday on the New York Stock Exchange after rising to a new high of $71.99 earlier. (Reporting by Bill Berkrot; Editing by Andrew Hay, Steve Orlofsky and M.D. Golan)

Abbott Laboratories releases data on PILOT & CO-PILOT studies...

The EASL madness begins! An article posted today on Wall Street Journal.com below on Abbott's (or soon-to-be spin-off AbbVie) PILOT and CO-PILOT studies looking at protease inhibitor ABT-450 and polymerase inhibitors ABT-072 and ABT-333.  These studies are remarkable for a couple of reasons in my view:

• Interferon-free regimens, at least for certain populations, is really a reality.
• An SVR12 of at least 90% (in the tx-naive, no complications populations) is the new 75% of last year.
• The majority of large pharma companies now in the HCV marketplace is astounding. Competition will be fierce.
• The prospects of a Novir-boosted HCV PI is questionable, especially with 4 severe adverse events attached to it. 
• The drug to really, really beat is Ribavirin. Don't say I didn't tell you so. 

This EASL is going to be a big one for HCV drug development - stay tuned!

Abbott Drugs Suppress Hepatitis C Virus In 2 Studies

--Abbott is testing several experimental hepatitis C drugs

--More than 90% of patients with no prior treatment in one study had suppressed virus 12 weeks after treatment

--Abbott is targeting launch of hepatitis C regimen in 2015

(Adds details of a Bristol-Myers study in final paragraph; updates stock prices.)


   By Peter Loftus
   Of DOW JONES NEWSWIRES

Experimental drugs from Abbott Laboratories (ABT) suppressed the hepatitis C virus in most patients in two small, midstage studies.

The results unveiled Wednesday could reinforce Abbott's position as a key player in an industry race to bring the next generation of drugs to what is expected to be a multibillion-dollar market for hepatitis C therapies. The drugs' safety and efficacy, however, need to be confirmed in additional studies.

"The Abbott data are clearly impressive from an efficacy perspective," said ISI Group analyst Mark Schoenebaum.

Abbott shares rose 36 cents, or 0.6%, to $61.50 in recent trading, and earlier set a 52-week high of $62.57.

Abbott has said it could begin selling a new hepatitis C regimen in 2015, and sales could eventually exceed $2 billion annually. The drugs would be sold by the pharmaceutical business that Abbott plans to split off into an independent company later this year, to be named AbbVie.

Summaries of the Abbott studies and studies of other liver-disease drugs were posted online Wednesday by the European Association for the Study of the Liver, or EASL, in advance of its annual scientific meeting in Barcelona in mid-April. Some EASL study results won't be released until the conference begins in two weeks, including data for key drugs from Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. (BMY).

Gilead, Bristol-Myers, Vertex Pharmaceuticals Inc. (VRTX) and Merck & Co. (MRK) are among several companies developing hepatitis C drugs to tap a market that research firm Decision Resources predicts will hit $16 billion in 2015, up from just $1.7 billion in 2010.

Hepatitis C is a viral disease that attacks the liver, and is believed to afflict about 180 million world-wide, with more than 4 million in the U.S., according to the National Institute of Allergy and Infectious Diseases. At-risk groups include people who had blood transfusions before 1992, when a screening test for the virus was developed.

Abbott is developing several potential hepatitis C drugs. One of them, ABT-450, is a so-called protease inhibitor, which is the same class of drugs as two that went on sale last year, Merck's Victrelis and Vertex's Incivek, which is marketed outside the U.S. by Johnson & Johnson (JNJ) as Incivo.

The protease inhibitors advanced treatment of hepatitis C, but there is still room for improvement because current treatments require an injectable drug, interferon, that can be difficult for patients to tolerate. Abbott and other companies want to develop all-oral regimens that eliminate the need for interferon.

In addition, Abbott is developing two polymerase inhibitors, ABT-072 and ABT-333, which have different mechanisms of action than the protease inhibitors.

The two studies released Wednesday each focused on ABT-450. One, titled "Co-Pilot," involved 50 patients who were given the following: one of two different dose levels of ABT-450, combined in the same pill with Abbott's Norvir boosting agent; ABT-333; and an existing drug called ribavirin that is part of the current standard of care for hepatitis C. The regimen amounted to several pills taken daily.

The study tested safety and tolerability of a 12-week regimen of the drugs in people with the most common form of hepatitis C, known as genotype 1. Patients in the study either hadn't previously received any treatment or didn't respond to prior treatment.

In the treatment-naive patient groups, more than 90% had a sustained virologic response 12 weeks after the end of treatment, a measure known as SVR12. Sustained virologic response is roughly equivalent to being virus-free or having nearly undetectable viral levels.

In the patients who didn't respond to prior treatment, 47% achieved SVR12 in the Abbott-funded study.

The second, smaller study--called "Pilot"--combined ABT-450 boosted by Norvir, ribavirin, and ABT-072. All 11 patients had received no prior therapy. This group of patients had a subtype of the virus that generally responds well to an interferon-based regimen and thus considered among the easier forms to treat.

Ten of the 11 patients achieved a sustained virologic response 24 weeks after stopping treatment, for an SVR24 rate of 91%. One patient relapsed.

"We're showing a sustained, post-treatment response from 12 to 24 weeks out" from the end of treatment, said Scott Brun, divisional vice president of infectious disease development at Abbott.

In both studies, the most common adverse events included headache, fatigue and nausea, and most were mild. In the larger "Co-Pilot" study, four patients had severe adverse events including fatigue and vomiting. There were no deaths in either study.

Abbott is conducting larger mid-stage studies testing various combinations of the three experimental drugs used in the smaller studies, Brun said. Abbott hopes to move some combination of the drugs into late-stage testing next year.

Abbott has developed ABT-450 in collaboration with Enanta Pharmaceuticals.

Shares of some of Abbott's rivals in the hepatitis C field declined Wednesday. Idenix Pharmaceuticals Inc. (IDIX) dropped 14% to $8.77; Gilead was off 1.85% at $47.21; Vertex was down 2.5% at $40.73, and Bristol-Myers was down 0.6% at $33.66.

A summary of a Bristol-Myers study posted Wednesday by EASL showed that a regimen of the drugs daclatasvir and asunaprevir helped 90.5% of hepatitis C patients who hadn't responded well to prior therapy achieve sustained virologic response 12 weeks post-treatment. Some 64% of patients who were ineligible for interferon-containing regimens or who discontinued prior therapy for intolerance achieved SVR 12 with the Bristol regimen.

-By Peter Loftus, Dow Jones Newswires; 215-982-5581; peter.loftus@dowjones.com

Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy...

Although it's still early in the clinical trial process, the news gets better and better with Direct Acting Antivirals as we head toward AASLD. This press release from Abbott focuses on Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072. Interim data points toward shortening therapy down to 12 weeks with ribavirin but sans interferon. Abbott doesn't specifically go into adverse events in this press release, which is a question everyone will likely be asking at the conference.

Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy

pharmpro.com

Oct 24 2011
Abbott on Friday announced interim data from mid-stage trials of its experimental hepatitis C drug combination that suggested patients could achieve a viral cure without use of interferon and that the duration of therapy could be about half as long as conventional therapies. Abbott’s Richard Gonzales, who will take over as CEO of the company's new presecription drug business following its split, commented that the therapy could "dramatically change the treatment landscape" for the disease, adding that "we’re on track to show patient cure rates in the 90 percent range."

In the trials, 44 previously untreated patients with hepatitis C were given ritonavir with Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin for 12 weeks. All patients who remained in the studies achieved an early virologic response at 12 weeks, and of the 10 patients to date who were tested 24 weeks after completing the treatment course, nine had achieved a sustained virologic response, the company said. Abbott plans to present more detailed data on these and other trials of the drug regimen next year.


"While early, these results are unprecedented in that very high cure rates are being achieved ... with only 12 weeks of interferon-free therapy," Gonzalez commented. Abbott noted that the FDA has given fast track status to the regimen and indicated that it could reach the market by 2015. In addition, the drugmaker speculated that the treatment regimen could go on to capture $2 billion in annual sales.


Shares in Pharmasset, which is developing a similar therapy that includes two drugs versus Abbott’s four components, dipped 15 percent on the news. Investors had expected that Pharmasset’s treatment would not face competition from another therapy that doesn’t use interferon, commented Leerink Swann analyst Howard Liang. "We are seeing there is another way of achieving a regimen without interferon that looks like it will be competitive," he said, adding that "it will eventually all boil down to who has the better data."


However, Brean Murray Carret & Co. analyst Brian Skorney noted that "the two-drug combination has a better chance of a very clean safety profile. I continue to believe Pharmasset’s [therapy] will be better." Pharmasset will present new data on the therapy next month at the American Association for the Study of Liver Disease annual meeting.