December 21, 2015
By Alex Keown, BioSpace.com Breaking News Staff
HUDDINGE, Sweden -- Janssen Pharmaceutical pulled the plug on an early-stage trial for an experimental chronic hepatitis C treatment it was developing with infectious disease research company Medivir AB , the company announced this morning.
According to a company statement the Phase I trial of AL-704 was terminated after results showed “clinical antiviral activity in persons infected with HCV genotype 1 was insufficient to justify further clinical studies.” AL-704 is a nucleotide based NS5B polymerase inhibitor intended for the treatment of chronic hepatitis C virus (HCV) infection in combination with other direct acting antiviral agents. Trial data did show that AL-704 was “safe, well tolerated and had acceptable pharmacokinetic properties.”
Medivir was working in collaboration with Alios BioPharma, Inc., a division of Janssen. Medivir entered into an agreement with Janssen for the research and development of HCV polymerase with in May 2008. AL-704 is the second candidate drug under this agreement that enters into clinical development.
The Phase I trial was a “randomized, double-blind, placebo-controlled, three-part study” of the oral HCV AL-704 for healthy volunteers as well as patients with chronic hepatitis C infection of genotype 1 and 3.
There are estimates of 150 million people globally infected with HCV. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However the infection is curable with combinations of antiviral agents, and nucleotide inhibitors of the viral polymerase have been shown to be central to some of the most effective drug combinations for treating HCV.
There are several highly effective HCV treatments available, including Gilead Sciences, Inc. ’s blockbusters Sovaldi and Harvoni. While highly effective, both drugs have been criticized for their high price tags, about $84,000 for a 12-week regimen. Sovaldi has had a 90 percent efficacy in curing, not treating, but curing, the liver disease when used with other treatments—surpassing older treatments. Earlier this month Harvoni was approved for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV by the U.S. Food and Drug Administration. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis
The termination of the AL-704 trial with Janssen ends Medivir’s license agreement with that company on HCV NS5B polymerase inhibitors. With the termination of that agreement, Medivir said it will not receive any additional revenues from the deal
Termination of this project does not affect the MIV-802 project, which is wholly owned by Medivir, nor any of the products or compounds in other partnerships with Janssen, Medivir said.
In addition to the now terminated AL-704, Janssen’s Alios has been developing an additional HCV treatment with Medivir. In October, the companies started a phase IIa clinical trial to evaluate the combination of simeprevir, odalasvir and AL-335 in treatment-naïve patients with genotype 1 chronic hepatitis C.
Medivir is listed on the Nasdaq Stockholm Mid Cap List.
