Presidio Pharmaceuticals announce new HCV pan-genotypic non-nuc polymerase inhibitor....

Posted on MarketWatch, 4/21/12.  Presidio releases pre-clinical profile of it's new novel pan-genotypic non-nuc polymerase inhibitor PPI-393 at EASL. It will be a very competitive environment for HCV drugs just getting started in development given the high bar set with interim SVR data presented for the 2nd generation HCV drugs at EASL.  New drugs in development will have to offer a significant advantage in respect to resistance profile, dosing, tolerability and efficacy to compete. 

PRESS RELEASE

April 21, 2012, 2:00 a.m. EDT

Presidio Pharmaceuticals Announces a New Clinical Candidate, PPI-383, a Novel Pan-Genotypic Non-Nucleoside Polymerase Inhibitor for HCV

Pre-Clinical Profile to be Presented at the 47th European Association for the Study of the Liver (EASL) Meeting

SAN FRANCISCO, Apr 21, 2012 (BUSINESS WIRE) -- Presidio Pharmaceuticals, Inc. announced today that PPI-383, a novel non-nucleoside polymerase inhibitor to treat hepatitis C virus (HCV), has been nominated for clinical development and will be profiled by Richard Colonno, Ph.D., Chief Scientific Officer, in poster 1173 at the 47th Annual EASL meeting being held in Barcelona, Spain on April 21st, 2012.

PPI-383 is a potent, pan-genotypic inhibitor of HCV discovered at Presidio, which exhibits a favorable pharmacokinetic and safety profile in multiple animal species following oral dosing. PPI-383 binds to the Palm II pocket of the HCV polymerase (NS5B) and possesses excellent biochemical and pharmaceutical properties critical to successful drug development, including a potential for once-daily oral dosing and minimal potential for drug-drug interactions. PPI-383 is currently undergoing further preclinical evaluation to support initiation of clinical studies alone and in combination with PPI-668 next year.

PPI-383, identified through an extensive medicinal chemistry effort, exhibits EC50s of 8.3 and 2.2 nM in HCV 1a and 1b replicon assays, respectively. PPI-383 is also active against other major HCV genotypes (2a, 3a and 4a) in stable replicon cell assays (EC50s of 4.4-11.7 nM). "The selection of PPI-383 underscores Presidio's continued commitment to generate best-in-class compounds for treating HCV," commented Dr. Colonno, who added, "It is an excellent complement to our lead NS5A inhibitor, PPI-668, currently completing Phase 1b clinical studies. We intend to develop oral, combination regimens that possess potent, pan-genotypic activity." The distinct mechanism of action of PPI-383 will potentially allow its use in combination regimens with all other classes of HCV inhibitors.

Poster 1173, entitled "Identification and Characterization of PPI-383, a Next Generation HCV NS5B Non-Nucleoside Inhibitor with Potent Activity Against all Major HCV Genotypes" will be presented by Dr. Colonno on Saturday, April 21st, 2012 at the Centre Convencions Internacional Barcelona (CCIB) from 8:00 AM to 5:00 PM.

About HCV

Chronic hepatitis C is a persistent, potentially progressive inflammatory liver disease caused by chronic infection with the hepatitis C virus (HCV). Worldwide, there are an estimated 130 to 170 million persons with chronic HCV infection, with over 350,000 deaths occurring each year.

The current standard treatment for hepatitis C in the United States, for patients with HCV genotype-1 infection, is combined administration of pegylated-interferon-alfa, ribavirin, and an HCV protease inhibitor. This multi-drug treatment is characterized by incomplete efficacy for HCV genotype-1 patients, variations in efficacy according to patients' underlying human genetic factors, no established efficacy for patients infected with other HCV genotypes, severe side effects in some patients, and dosing inconveniences. In countries where the current HCV protease inhibitors are not yet regulatory-approved, standard treatment is only pegylated-interferon-alfa plus ribavirin, which is less effective.

There is a continuing need for all oral, more consistently effective and better tolerated antiviral combinations for HCV infection, regardless of HCV genotype, patient genetic factors, or disease stage.

About Presidio

Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics. For more information, please visit our website at: www.presidiopharma.com .

SOURCE: Presidio Pharmaceuticals, Inc