Vertex VX-950 cuts hepatitis C in initial response to dosing

By E. Janene Geiss

Philadelphia, Feb. 7 - Vertex Pharmaceuticals Inc. announced Tuesday that it has completed dosing with VX-950 in a phase 2, 28-day clinical study in hepatitis C virus patients - with initial results showing plasma hepatitis C RNA was undetectable in all 12 patients treated by the end of administration of the treatment.

The company also has completed three-month animal toxicology studies that will support clinical studies of VX-950 of up to three months duration, according to a company news release.

Initiation of additional phase 2 clinical studies in the United States in patients with hepatitis C virus is planned following required Food and Drug Administration review of these latest non-clinical and clinical results and a proposed clinical study protocol.

This information will be submitted to the FDA within the first quarter of 2006, officials said.

The 28-day, phase 2 clinical study enrolled 12 treatment-naïve patients with genotype 1 hepatitis C.

Patients received VX-950 in a tablet formulation at a dose of 750 mg every eight hours for 28 days in combination with standard doses of pegylated interferon alfa-2a (Pegasys; peg-IFN) and ribavirin (Copegus; RBV).

At the end of 28 days, patients completed dosing with VX-950 and per study protocol were required to continue treatment with peg-IFN and RBV, officials said.

The study was not designed to evaluate sustained viral responses in patients receiving VX-950, officials said.

There were no treatment discontinuations and no serious adverse events reported. A detailed safety analysis is ongoing.

For patients entering the study, the distribution of baseline plasma hepatitis C RNA values was typical for a treatment-naïve patient population.

At the end of week 1, plasma hepatitis C RNA was below the limit of quantitation in six of the 12 patients and undetectable in two of 12 patients, officials said.

Preliminary hepatitis C RNA results in patients for weeks two through four include:

• At the end of week two, plasma hepatitis C RNA was below the limit of quantitation in 11 of the 12 patients and undetectable in three of 12 patients;

• At the end of week three, plasma hepatitis C RNA was below the limit of quantitation in 12 of the 12 patients and undetectable in nine of 12 patients;

• At the end of VX-950 dosing, plasma HCV RNA was undetectable in all 12 patients; and

• No patients showed evidence of viral breakthrough while on treatment.

The phase 2 study reported Tuesday is the third in a series of clinical trials of VX-950 in patients with hepatitis C designed to evaluate safety, pharmacokinetics and antiviral activity in order to guide the design of larger, longer duration phase 2 studies.

The company said it plans to present the full data set from the study at a medical conference later this year.

Vertex Pharmaceuticals is a Cambridge, Mass., biotechnology company that develops small molecule drugs for serious diseases with a focus on viral diseases, inflammation, autoimmune diseases and cancer.

The company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex co-promotes the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

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