EASL Round Up

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EASL Round Up

The following news emerged from the annual meeting of the European Association for the Study of the Liver in Vienna, Austria:

• Avila Therapeutics Inc., of Waltham, Mass., presented results of preclinical studies on two of its hepatitis C virus protease inhibitors, AVL-181 and AVL-192. The inhibitors achieved sustained, irreversible silencing of HCV protease. The company said they have the potential as best-in-class, pan-genotype HCV therapeutics.• Biolex Therapeutics Inc., of Pittsboro, N.C., said that EMPOWER, a prospectively designed analysis of results from two Phase IIb trials of Locteron, showed the 480 mcg dose demonstrated viral kinetics and response rates that were comparable to the PEG-Intron control, while also achieving a 57 percent reduction in flu-like adverse events. The 133 patients in the EMPOWER study were enrolled in two contributing Phase IIb trials.• Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported in vitro data for hepatitis C virus protease inhibitor IDX320, demonstrating potent and selective

antiviral activity in multiple genotypes of the virus. Additional data showed that a combination of three Idenix drug candidates, including IDX320, with different mechanisms of action produced strong synergy in vitro.• Ocera Therapeutics Inc., of San Diego, presented an analysis of the prevalence of neurocognitive impairment in ambulatory cirrhotic patients, showing that a majority of patients have a neurocognitive deficit and suffer from mild hepatic encephalopathy. Those data came from an ongoing Phase IIb trial of AST-120 (spherical carbon adsorbent). Ocera also presented data demonstrating the potential of AST-120 to lower ammonia and reduce brain edema in a preclinical model of cirrhosis.• Scynexis Inc., of Research Triangle Park, N.C., reported results from two studies of SCY-635, an oral, cyclophilin inhibitor designed to treat hepatitis C virus infection. Data from an in vitro study showed that, unlike other cyclophilin

inhibitors, SCY-635 is not associated with an increased risk of hyperbilirubinemia in 15-day clinical studies. A second presentation outlined the effects of the drug in in vitro studies on collagen production and fibrosis, suggesting that it might have an antifibrotic effect independent of demonstrated anti-HCV activity. SCY-635 is set to enter Phase II in the second half of this year.

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Also See:

Boceprevir-The drug — developed by Schering-Plough, which merged with Merck in November 2009 — is now in a fully enrolled phase 3 trial. Merck officials expect to file the Food and Drug Administration application later this year, and they hope for approval in 2011.

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Genotype 1 chronic hepatitis C patients treated with the Merck/Schering-Plough's investigational NS3 HCV protease inhibitor boceprevir plus pegylated interferon (with or without ribavirin) achieved durable sustained response with no evidence of viral rebound or adverse events lingering after completion of therapy, according to a late-breaker poster presented this week at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) in Vienna.

Boceprevir Hepatitis C Patients Continue to Fare Well, Data Show

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Vertex Telaprevir plus Pegylated Interferon/Ribavirin regimen has increased the rate of SVR over 50 percent in previous treated persons , depending on the type of previous treatment failure they had. For those of us who are genotype 1 (most difficult to treat) who did not achieve (SVR) the first time you treated with Interferon-based therapy, you too have more then a 50 percent chance to reach SVR treating with the HCV Protease inhibitor telaprevir plus Pegylated Interferon/Ribavirin according to what Vertex presented this April to the "EASL 2010" in Vienna.

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The Stats

Almost all prior relapsers achieved SVR, prior null responders had the lowest odds of successful treatment..59 Percent of Patients Overall Achieved SVR with Telaprevir-Based Regimens in Study 107After Not Achieving SVR with at Least One Prior Course of Treatment for HCV Infection;-56% of prior treatment null responder patients achieved SVR with a 48-week telaprevir-based regimen--97% of prior treatment relapsers and 55% of prior treatment partial responders achieved SVR with 24-week or 48-week telaprevir-based regimens

- ,Click Below For the Full Results from EASL 2010:

,Telaprevir-Based Regimens in Study 107

TELAPREVIR NAÃVE Geno 2 & 3/ FINAL RESULTS OF STUDY C209

Telaprevir Produces Good Response Rates in Nonresponders With HCV

Telaprevir or Boceprevir

..AUDIO/CCO Independent Conference Coverage Marcellin, MD, highlights key data with novel anti-HCV treatments currently under investigation in clinical trials.One Drug Covered is The HCV protease inhibitor telaprevir plus pegylated interferon and ribavirin

Audio/From/CCO-New HCV Drugs/Telaprevir etc.

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Vertex/In the trial, treatment with VX-222 for three days was well-tolerated, with all adverse events being mild to moderate in severity. Dosing with VX-222 for three days resulted in a greater than 3 log10 reduction in HCV RNA across all four of the VX-222 dosing groups. No serious adverse events or treatment discontinuations were reported in the Phase 1b trial. The results from this trial support the Phase 2 proof-of-concept clinical trial of VX-222 dosed in combination with Vertex?s lead investigational HCV protease inhibitor telaprevir, which is expected to complete enrollment in the second quarter of 2010. Vertex retains worldwide rights to VX-222.

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Hepatitis C Virus Polymerase Inhibitor VX-222 Reduced Viral Levels Over Three Days in Phase 1b Trial

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Check Out NATAP EASL Summary.

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EASL/Coverage VX-222 polymerase inhibitor and More

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