Tirasemtiv: Phase IIb ongoing

Cytokinetics said 58 patients initially treated with tirasemtiv were accidentally switched to placebo in the international Phase IIb BENEFIT-ALS trial. The company said it was notified of the issue by its data management vendor, which attributed the issue to a programming error. Cytokinetics said it "is in communication with regulatory authorities" about how to address the error. The company said it will provide an update on whether it will need to increase enrollment in the trial and when it expects to release data from the trial, but did not disclose details. Cytokinetics has enrolled over 450 of a planned 500 ALS patients in the trial. The company previously said data were expected this year. BENEFIT-ALS is evaluating 125 mg tirasemtiv twice daily in a 1-week, open-label period, which will be followed by a 12-week, double-blind, placebo-controlled period evaluating ascending doses of twice-daily tirasemtiv starting at 125 mg and increasing weekly up to 250 mg. ...