Brilacidin: Phase IIb ongoing

Cellceutix said an independent DSMB recommended the continuation of a double-blind, U.S. Phase IIb trial of IV brilacidin based on an interim safety analysis after about 50% of the patients were enrolled. Cellceutix said there have been no treatment-related serious events in the trial, which has enrolled about 80% of a planned 215 patients with ABSSSI. The trial is comparing single doses of 0.6 and 0.8 mg/kg brilacidin or 0.6 mg/kg brilacidin on day 1 followed by 0.3 mg/kg brilacidin on days 2 and 3 vs. 4 mg/kg daily IV Cubicin daptomycin for 7 days.

The company plans to pursue an expedited regulatory review process for brilacidin in ABSSSI under the Generating Antibiotic Incentives Now (GAIN) program. GAIN, which creates incentives to develop new drugs against pathogens with “the potential to pose a serious threat to public health,” is part of the FDA Safety and Innovation Act signed into law last year. ...