Liver Meeting 2015: Merck combo shines for IV drug abusers, Genfit preps phase 3 for pioneering NASH med
- The American Association for the Study of Liver Diseases (AASLD) has been conducting its annual meeting in San Francisco, California—and BioPharma Dive is here to cover all the news coming out of the conference.
- Merck announced on Sunday that its once-daily hep C combo of elbasvir/grazoprevir achieved a 95% overall cure rate in a phase 3 trial for patients with HCV-1, -4, or -6 who are IV drug abusers. The combo was most effective against HCV-4 and HCV-1.
- On Monday, the French biotech Genfit will be presenting data on a phase 2 trial of its Non-alcoholic Steatohepatitis (NASH) drug Elafibranor. The company also announced that it plans to pursue a larger-scale phase 3 trial of the candidate before the end of the year, and that the drug could be approved as early as 2019 under the FDA's accelerated review process.
Amid sessions discussing everything from major recent progress in curing hepatitis C to gender disparities in the organ allocation system, Merck and Genfit both announced major promising data on liver disease treatments.
Merck's combo drug was tested in a population that is disproportionately afflicted by HCV. According to the CDC, IV drug users are at the highest risk of contracting the virus due to risky behaviors such as sharing needles, and between 50% and 80% of those who inject drugs like heroin wind up infected.
That's why Merck's results were so promising. The drug combo was tested in patients undergoing treatment for their opioid dependence, and it achieved cure rates in this population approaching the stellar numbers for Gilead's HCV meds. The FDA is expected to decide on the drug's regulatory fate by the end of January 2016.
As for Genfit, the French company is trying stake its claim in a market with a dearth of effective treatment options. NASH doesn't currently have a cure, and the market could be worth tens of billions of dollars, according to Reuters. Other companies such as Intercept have pursued their own phase 3 trials for NASH candidates only to come up short, and Genfit is aiming to buck that trend. The company also said that it is moving towards listing on the NASDAQ.
Stay tuned for more coverage from the Liver Meeting. You can follow along with us on Twitter @BioPharmaDive. We'll be using the hashtag #Liver15.