Chelsea Therapeutics International, Ltd. (CHTP) announced today that a preliminary analysis of its dose-ranging exploratory Phase II trial of CH-4051 (a non-metabolized antifolate for the treatment of rheumatoid arthritis) did not demonstrate superior efficacy to methotrexate in the dose range evaluated.
Dr. Simon Pedder, President and CEO of Chelsea Therapeutics, commented:
Results of this study provide evidence of the clinical activity of CH-4051, in a dose dependent manner, across multiple RA assessment criteria. 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(TM) (droxidopa) development program in neurogenic orthostatic hypotension. Consequently, we have no immediate plans to continue development of CH-4051.
CHTP shares plunged over 31% on the 4X 3month volume average.
Chelsea Therapeutics, Inc.
3530 Toringdon Way, Suite 200
Charlotte, NC 28277
Tel: 704-341-1516
Fax: 704.752.1479
Chelsea Therapeutics specializes in the acquisition and development of innovative products and technologies that address important unmet medical needs or offer alternatives to current methods of treatment.
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