Idenix pharmaceuticals Inc. said it started a Phase III trial of its lead hepatitis B candidate, telbivudine, and plans to begin Phase I/II studies of NM283, a proposed treatment for hepatitis C, by the end of January.
"This demonstrates that we can move very rapidly on the development of hepatitis drugs, and our company is able to develop first-in-class drugs. This hepatitis C [product] is the first nucleoside analogue for the treatment of hepatitis C," Jean-Pierre Sommadossi, Idenix's chairman and CEO said. "We hope it will be a major addition to the treatments for hepatitis C."
Idenix, formerly Novirio Pharmaceuticals Ltd., employs 120 people in its Cambridge, Mass., and European facilities. Unfavorable market conditions forced the privately held company to withdraw its proposed initial public offering in December. Idenix filed the IPO in April, estimating a $115 million offering. Last May, Idenix dropped its former name, Novirio, citing the desire to carry a name reflective of its knowledge in the areas of hepatitis B, hepatitis C and HIV.
Sommadossi said the company is in the process of enrolling 1,200 patients in the international Phase III trial of telbivudine. The program will include 120 sites in Asia, Europe and North America, and it's designed to evaluate telbivudine compared with standard treatment in patients with HbeAg+ and HbeAg- compensated liver disease.
Interim data from the 24-week ongoing Phase IIb trial of telbivudine demonstrated a median reduction in serum virus load for all LdT-containing arms of greater than 6 log10, or a millionfold. A median reduction of 4.67 log10 occurred in patients receiving lamivudine alone, the company said.
Sommadossi said final analysis of the Phase IIb is not complete.
He believes Idenix will be in a position to file a new drug application based on the Phase III trial.
The company has a second hepatitis B candidate, valtorcitabine, in Phase I/II trials. Sommadossi said that product is being developed for use as a fixed-dose combination therapy with telbivudine.
Meanwhile, in HCV, Idenix is preparing to begin a Phase I/II randomized, multicenter study of NM283, an oral, small-molecule, once-daily treatment. The study is designed to evaluate safety and short-term antiviral activity of NM283 in adults with chronic hepatitis C infection and to assess optimal dosing levels of NM283 for future large-scale trials, the company said.
Trial participants will include previously untreated patients with genotype 1 HCV infection (an infection type that has a low response rate to existing treatments), and patients who have failed prior interferon-based treatment.
Idenix is developing telbivudine in collaboration with Tokyo-based Sumitomo Pharmaceuticals Co. Ltd., for Japan and Asian markets, in a deal valued at $46 million. Idenix retains commercial rights outside the Asian countries. The company also retains rights to the other candidates, but anticipates forming partnerships in the future where such deals could maximize the commercial benefit of the products.
BioWorld Today January 10, 2003