Trial Set of Pralnacasan as Rheumatoid Arthritis Treatment

Aventis and Vertex Pharmaceuticals are moving ahead in their efforts to develop the drug pralnacasan as a treatment designed to curtail the inflammatory processes common to rheumatoid arthritis.

The companies announced July 10 that enrollment had begun for a Phase IIb clinical trial of pralnacasan, an orally administered interleukin beta converting enzyme (ICE) inhibitor.

ICE regulates the production of both interleukin-1 beta and interleukin-18, key pro-inflammatory cytokines that initiate and sustain the progression of inflammation.

The trial involving 400 patients will evaluate the safety and efficacy of pralnacasan in rheumatoid arthritis patients being treated with stable methotrexate. Participants will either receive pralnacasan or a placebo for 12 weeks.

The companies are also conducting a 12-week study to evaluate the safety and effectiveness of pralnacasan in the treatment of osteoarthritis. In April, the companies announced that this study was fully underway. The companies expect to report results in the fourth quarter of 2003.

The companies also announced that they plan to further expand development of pralnacasan in the indication of psoriasis.

"The biological and clinical rationale for the use of cytokine inhibitors across major inflammatory diseases is compelling, and oral agents such as pralnacasan have the potential to transform the way that diseases such as rheumatoid arthritis, osteoarthritis and psoriasis are treated," said Vicki Sato, president of Vertex Pharmaceuticals.

Other sources: Aventis, Vertex Pharmaceuticals