October 29, 2002
Vertex (NASDAQ: VRTX) and Aventis’s (NYSE:
AVE) pralnacasan (HMR3480/VX-740) generated phase IIa data suggestive of a modest therapeutic effect for patients with rheumatoid arthritis (RA). The data, presented at the American College of Rheumatology (ACR) Meeting, support continued clinical trials designed to clarify pralnacasan’s magnitude of therapeutic effect. The drug is an orally active inhibitor of interleukin-1 beta converting enzyme (ICE), and is being investigated for its utility in a variety of inflammatory conditions.
285 adult study subjects were studied in a 12-week, randomized, double blind, placebo- controlled trial. Subjects received either pralnacasan 100 mg, pralnacasan 400 mg or placebo thrice daily. Co-administration of biological treatments and immunosuppressive therapies were not permitted.
Pralnacasan 1200 mg/day provided 44% of recipients with ACR20 achievement compared to 32.7% of placebo recipients. Subset analyses revealed significant ACR20 achievements when patients on methotrexate <6 months were excluded from the analysis and in subsets of patients receiving either concomitant stable (>6 months) methotrexate therapy or no methotrexate therapy. Pralnacasan 1200 mg/day also led to statistically significant reductions in the inflammatory surrogate markers C- reactive protein, erythrocyte sedimentation rate, and serum amyloid A. Pralnacasan therapy enabled patients to reduce their concomitant corticosteroid requirements.
Our modeling estimates the probability of pralnacasan approval for RA at 25-35%.
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