Idenix says first four weeks of phase 2b valopicitabine trial shows promise for hepatitis C patients

By E. Janene Geiss

Philadelphia, Jan. 9 - Idenix Pharmaceuticals, Inc. said Monday that partial four-week data from an ongoing phase 2b clinical trial demonstrating that treatment with valopicitabine combined with pegylated interferon resulted in rapid and marked reduction in virus levels in treatment-naive genotype 1 hepatitis C patients.

The mean reduction in virus levels was greater than or equal to 4 log10, or 99.99%, after four weeks of treatment among patients in the two dose groups that began on day 1 with 800 mg doses of valopicitabine, according to a company news release.

This trial is almost fully enrolled, officials said, with a target enrollment of 175 patients at more than 20 medical centers in the United States.

These partial data will be presented at the 24th Annual JP Morgan Healthcare Conference on Wednesday, officials said.

"We are quite encouraged by the virologic responses demonstrated to date with these four-week data and believe that valopicitabine combined with pegylated interferon has the potential to substantially improve treatment efficacy compared to current therapy for chronic hepatitis C patients," Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix, said in the release.

The ongoing 48-week trial in treatment-naive patients includes five randomized treatment arms, all involving dosing regimens of valopicitabine, administered once-daily, in combination with pegylated interferon alfa-2a (Pegasys) 180 5g per week

The partial data demonstrated that the four treatment arms that included valopicitabine in combination with pegylated interferon during the first four weeks all produced proportionally greater suppression of serum HCV RNA as compared to the arm that included pegylated interferon alone for the first four weeks, officials said.

Rapid virologic response, or a greater than or equal to 2 log10 reduction in viral load by week 4, was achieved in 93% of patients in the two 800 mg dose valopicitabine arms, indicative of a degree of virologic response which, in treatment naive patients, is thought to correlate with potentially sustained viral clearance post treatment, officials said.

Preliminary data from the first four weeks indicate valopicitabine continues to demonstrate adequate tolerability when administered in combination with pegylated interferon. Of the 150 patients enrolled in the trial to date, 10 patients discontinued treatment by week four, nine discontinuations were due to adverse events, including one of severe dehydration, and one for logistical reasons, officials said.

The company said it plans to start a phase 3 clinical trial in this patient population in the second half of 2006.

Idenix Pharmaceuticals is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.

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