>> Idenix Pharmaceuticals Reports Positive 4-Week Data From A Phase IIb Clinical Trial Evaluating Valopicitabine (NM283) Combined with Pegylated Interferon in Treatment-Naive Hepatitis C Patients
Monday January 9, 8:03 am ET
SAN FRANCISCO, Jan. 9 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) announced partial 4-week data today from an ongoing phase IIb clinical trial demonstrating that treatment with valopicitabine combined with pegylated interferon resulted in rapid and marked reduction in virus levels in treatment-naïve genotype 1 hepatitis C patients. The mean reduction in virus levels was greater than or equal to 4 log10, or 99.99 percent, after 4 weeks of treatment among patients in the two dose groups that began on Day 1 with 800 mg doses of valopicitabine. This trial is almost fully enrolled, with a target enrollment of 175 patients at more than 20 medical centers in the U.S. These partial data will be presented at the 24th Annual JP Morgan Healthcare Conference on Wednesday, January 11 at 2:00 p.m. (PST).
"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," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We look forward to presenting additional data from this phase IIb clinical trial in the spring and initiating a phase III clinical trial in this patient population in the second half of 2006."
The partial 4-week data demonstrated that the four treatment arms that included valopicitabine in combination with pegylated interferon during the first four weeks (arms B-E) all produced proportionally greater suppression of serum HCV RNA as compared to the arm that included pegylated interferon alone for the first four weeks (arm A). At Week 4, mean HCV RNA reductions were 4.00 log10, 4.17 log10, 3.50 log10 and 3.09 log10, respectively, for arm E (15 patients), arm D (14 patients), arm C (18 patients) and arm B (17 patients). In comparison, patients in the arm receiving pegylated interferon alone for the first 4 weeks (arm A, 19 patients) achieved a mean HCV RNA reduction of 2.00 log10 . The mean HCV RNA reduction for the two 800 mg dose valopicitabine arms (arms D and E) was significantly greater than that of the pegylated interferon alone arm (arm A) (p<0.01). The addition of 800 mg of valopicitabine to pegylated interferon (arm D) led to viral clearance (PCR- negativity) in 50 percent of patients, compared to 11 percent in arm A, at Week 4.
Rapid virologic response (RVR), or a greater than or equal to 2 log10 reduction in viral load by Week 4, was achieved in 93 percent of patients in the two 800 mg dose valopicitabine arms (arms D and E), indicative of a degree of virologic response which, in treatment naïve patients, is thought to correlate with potentially sustained viral clearance post treatment.
Preliminary data from the first 4 weeks of treatment indicate valopicitabine continues to demonstrate adequate tolerability when administered in combination with pegylated interferon. Of the 150 patients enrolled in the trial to date, ten patients discontinued treatment by week four; nine discontinuations were due to adverse events (including 1 SAE of severe dehydration), and one for logistical reasons.
About Valopicitabine
Valopicitabine, which is administered orally once a day, is intended to block HCV replication by specifically inhibiting the HCV RNA polymerase, the enzyme that makes new copies of HCV viral chromosome inside infected cells. Data from the phase I clinical trial sponsored by Idenix demonstrated that valopicitabine is active in patients infected with the genotype 1 strain of HCV, the strain that infects the majority of patients in North America, Europe, and Japan. The ongoing phase II clinical trials are designed to evaluate the combination of valopicitabine and pegylated interferon in hepatitis C genotype 1 patients who previously failed to respond to antiviral treatment, as well as in genotype 1 patients who have not been treated previously. Preliminary results from these phase II clinical trials to date have demonstrated that the antiviral effect of valopicitabine is enhanced when this agent is used in combination with pegylated interferon. <<
Piper Jaffray upgraded shares of Vertex Pharmaceuticals to "outperform" from "market perform" and said a potential change to an upcoming clinical trial reduces risk in the development of the biotech firm's lead drug VX-950.
Citing conversations with "people close to the study," analyst Rachel McMinn said a Phase II trial of the promising hepatitis C will now include a third arm that will assess 24-weeks of dosing, in addition to the previously announced 12-week dosing arm.
"In our opinion, this new trial design alleviates a major risk factor for the VX-950 program," McMinn wrote Wednesday in a note to investors. "Our primary concern with VX-950 has been that 12 weeks of dosing may generate a less than optimal sustained virologic response rate."
The research analyst lifted the price target on the stock to $42 from $38. "We are upgrading Vertex … based on what we view as a positive development change for VX-950, which we expect will ultimately yield a very favorable clinical outcome," the analyst said.
McMinn said Vertex's "best-case scenario" for VX-950 would be for 12-week data to be favorable enough to validate a Phase III trial initiation in mid-2007, with a market launch in 2009. At the other end of the spectrum, the worst-case scenario would be for Vertex to wait for full 24-week data with a Phase III start at the end of 2007, and a launch in 2010.
Vertex is in a race with Schering-Plough to bring the first hepatitis C protease inhibitor to the market. Other companies working to bring new hepatitis drugs to the market include Idenix Pharmaceuticals, Anadys Pharmaceuticals and Valeant Pharmaceuticals.
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