Idenix hep C therapy misses endpoints in two trials
Indenix Pharmaceuticals is reporting that two mid-stage studies of its experimental therapy for hepatitis C failed to meet their primary endpoints. A Phase IIb trial combining valopicitabine (NM283) and Pegasys failed to see a sufficient number of patients respond to the treatment to hit the goal. Only 53 percent of the volunteers responded. A second trial of 178 patients comparing valopicitabine in combination with pegylated interferon against pegylated interferon and ribavirin saw no response in the valopicitabine group and one response in the ribavirn group. Idenix, though, says it was "encouraged" by the data and that the numbers warranted further investigation.
"We remain optimistic about the antiviral activity of the combination of valopicitabine and pegylated interferon (Pegasys) observed in various patient populations, and believe that multi-drug combinations will play an important role in the treatment of Hepatitis C genotype-1 infected patients," said Douglas L. Meyers, executive vice president and chief medical officer. "We are now working to define valopicitabine's role in therapy, not only in combination with the current standard of care, but also with other investigational compounds in development."
- see this release from Idenix for more
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