OMS824: Phase II suspended enrollment
Omeros suspended a double-blind, placebo-controlled, dose-escalation, U.S. Phase II trial evaluating oral OMS824 daily for 28 days in about 120 adults with symptomatic HD. Omeros' decision followed an unspecified observation in "several" rats receiving the maximum dose of OMS824, whose drug exposure was at an unspecified multiple of that observed in human patients. Omeros said it did not observe comparable results in nonhuman primates with drug exposures comparable to those in the rat study. CEO Gregory Demopulos declined to give further details about the observation or the dose in the rat study. FDA requested Omeros to further evaluate the rat study and other nonclinical trials before restarting the Phase II trial. Based on available data, Demopulos does not believe that OMS824 caused the observation and that existing data will support resumption of the suspended trial. ...