The signature drug from a Peninsula biotech company was bested in a mid-stage ulcerative colitis clinical trial by a placebo, according to top-line results, a result that at one point Friday sent the company's stock tumbling more than 60%.
More than 17% of 70 ulcerative colitis patients in the Phase II trial who received once-a-day AMT-101 had a"complete response," where all signs of the disease disappeared. The problem was that 20% of 35 patients who were given a placebo also had a complete response. "While we are disappointed with the top-line results, we are seeking to better understand the unexpectedly high placebo rate of clinical remission in this moderate-to-severe population," AMT Chief Medical Officer Dr.Kanwar added that AMT is"encouraged" by positive data of the same drug in patients with a condition known as chronic pouchitis. AMT is seeking a partner that would take AMT-101 into a late-stage study in that condition.