FDA asks Chelsea to delay its RA trial start
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
At FDA's request, Chelsea Pharmaceuticals will delay the start of its Phase II study of CH-4051 in rheumatoid arthritis and provide "additional detail" from already completed preclinical studies submitted with the IND, the company said June 9. The agency wants to "more fully characterize the safety of our proposed Phase II doses," the firm reported. The study is set to evaluate up to 3.0 mg daily oral dose of the antifolate in a 12-week head-to-head study against 20.0 mg weekly of methotrexate in RA patients with an inadequate response to methotrexate. In Phase I single and multiple ascending dose studies, CH-4051 was well-tolerated at doses up to and including 7.5 mg, a dose range likely to be effective for multiple autoimmune disorders, Chelsea said. In January, FDA asked Chelsea to refine its pivotal trial plan for lead candidate droxidopa, in studies for neurogenic orthostatic hypotension (1Pharmaceutical Approvals Monthly, January 2010). Phase III data from study 301, for which the company modified the primary endpoint and enrolled additional patients to increase the power, are expected in the third quarter. The company also expects to begin dosing in its confirmatory Phase III study (306) in June