ARTICLE | Clinical News

Brilacidin: Phase IIb started

February 24, 2014 8:00 AM UTC

Cellceutix began a double-blind, U.S. Phase IIb trial to compare single IV doses of 0.6 and 0.8 mg/kg brilacidin and 0.6 mg/kg IV brilacidin on day 1 followed by 0.3 mg/kg IV brilacidin on days 2 and 3 vs. 4 mg/kg daily IV Cubicin daptomycin for 7 days in about 215 patients with ABSSSI. 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. ...