Chelsea Therapeutics ($CHTP) has more bad news to report today. The developer says that its rheumatoid arthritis candidate CH-4051 failed to outperform the standard of care for the disease in a mid-stage study, forcing it to ax the program. And the announcement triggered a sharp 34% drop in share price as disappointed investors swallowed a fresh course in what's been a steady diet of bitter news.
Chelsea Therapeutics CEO Simon Pedder fingered "the unexpectedly robust response reported by patients treated with methotrexate" for the failure. And while he went on to assert that higher doses might deliver the needed data, adding that 4051 still had other promising indications in the anti-inflammatory field, Chelsea is axing the program as it stays focused on the fate of droxidopa (Northera).
A little more than two months ago the FDA handed Chelsea a rejection on its application for droxidopa, a treatment designed for symptomatic neurogenic orthostatic hypotension, the sudden drop in blood pressure that can trigger fits of dizziness for some 180,000 patients. Despite a positive panel review and vote, regulators determined that Chelsea needed to submit positive data demonstrating the drugs ability to perform over a two- or three-month period before it could win an approval.
Chelsea recently met with regulators and reported that it is planning to modify an ongoing study of the treatment, changing the endpoint and expanding the number of patients enrolled in the trial. The prospect of a fresh delay as Chelsea negotiated the terms of the study also took a bite out of the biotech's share price.
- get the press release
- here's the story from Reuters