Chelsea Therapeutics Reports Top-Line Results Of Phase II Study Of CH-4051

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5/31/2012 7:40 AM ET

Chelsea Therapeutics International Ltd. (CHTP: Quote) announced that a preliminary analysis of its dose-ranging exploratory Phase II trial of CH-4051, a non-metabolized antifolate, in patients with rheumatoid arthritis or RA, who experience an inadequate response to methotrexate treatment indicates that CH-4051 did not demonstrate superior efficacy to methotrexate in the dose range evaluated.

President and CEO of Chelsea Therapeutics said, "However, the outcome of the trial was confounded by the unexpectedly robust response reported by patients treated with methotrexate. While we believe that higher doses of CH-4051 could provide enhanced therapeutic benefit in RA and that CH-4051 could be developed for other anti-inflammatory and autoimmune indications, we believe our current resources would be better allocated toward the planned completion of our Northera (droxidopa) development program in neurogenic orthostatic hypotension."

The company said it has no immediate plans to continue development of CH-4051.

At the end of the 12-week period, patients treated with methotrexate showed greater improvement in both mean hACR and ACR20 response rate compared to patients treated with 0.3mg CH-4051, 1.0 mg CH-4051, 3.0mg CH-4051 or 3.0mg CH-4051 with folate supplement.

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