Chelsea Therapeutics, Inc. announced the initiation of a Phase I clinical trial in the UK of its lead orally available, metabolically inert antifolate (CH-1504), which, in a nonpivotal, independent, 6-month pilot clinical study involving 20 rheumatoid arthritis (RA) patients in Peru suggested a lower toxicity and improved tolerability, and increased effectiveness versus methotrexate (MTX), even among patients who had previously failed to demonstrate improvement with MTX. Scheduled to be conducted at Guy's Hospital in London, the Phase I, placebo-controlled, double-blind trial will evaluate the safety and tolerability of defined doses of CH-1504. The company anticipates that it will file an investigational new drug (IND) application later this year with the US Food and Drug Administration to initiate Phase II trials for both RA and psoriasis.

Early this year, Chelsea Therapeutics raised $14.5 million in a Series A private placement to support clinical development of CH-1504 and then completed a reverse merger to become publicly traded.