Vertex says VX-702 for rheumatoid arthritis met primary objectives in phase 2 study

By Lisa Kerner

Erie, Pa., March 8 - Vertex Pharmaceuticals Inc. said its investigational p38 MAP kinase inhibitor, VX-702, has met its primary objectives in a 12-week phase 2 clinical study involving 315 patients.

VX-702 was well-tolerated through 12 weeks of dosing. According to a company news release, VX-702 demonstrated statistically significant clinical effects on signs and symptoms of rheumatoid arthritis, as determined by ACR20 criteria and other clinical measures.

Vertex said it continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from the study, with study results presented later this year.

The company plans to begin clinical studies of VX-702 in combination with methotrexate, a commonly used therapy for rheumatoid arthritis, midyear.

"Demonstration of clear effects on the signs and symptoms of rheumatoid arthritis, in conjunction with good tolerability with three months of treatment, represents a major achievement for the VX-702 clinical program," executive vice president, medicines development and chief medical officer John Alam said in the release.

"The preliminary data announced today provide strong support for our plans to move forward in clinical development and evaluate VX-702 in combination with methotrexate in RA [rheumatoid arthritis] patients."

In the randomized, double-blind, phase 2 clinical study, known as VeRA, 278 of the 315 patients with moderate to severe rheumatoid arthritis enrolled completed 12 weeks of treatment.

Patients received either 5 mg or 10 mg VX-702 once daily, or placebo, plus certain disease-modifying anti-rheumatic drugs, the company said.

The study was conducted at more than 40 centers in Eastern and Central Europe.

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

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