Trial to Evaluate Higher Doses of Pralnacasan for Rheumatoid Arthritis

A Phase IIb clinical trial is expected to get underway in the second quarter of this year that will explore whether higher doses of the drug pralnacasan are effective and safe in treating rheumatoid arthritis.

Pralnacasan, which inhibits an enzyme regulating the inflammatory processes, is being developed by Aventis in conjunction with Vertex Pharmaceuticals. Vertex CEO Joshua Boger said the drug was proven to be clinically effective and safe for rheumatoid arthritis at lower doses.

"That energized us and Aventis for the broad potential of this oral potential disease modifying agent…in a variety of inflammatory diseases, looking at both rheumatoid arthritis and osteoarthritis and others. The goal has been to go for extended studies on rheumaoid arthritis to follow up on the positive Phase2a results and to begin Phase IIa studies this year on osteoarthritis."

The study of pralnacasan in osteoarthritis, which has already begun, will evaluate its safety and efficacy against a placebo in 400 patients for 12 weeks.

Vertex Pharmaceuticals Inc.