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Single-Dose Brilacidin Comparable With 7 Days of Daptomycin in Skin Infection Study
Positive results have been reported from a phase IIb randomized double-blind study comparing three dosing regimens of brilacidin (Cellceutix Corporation) with daptomycin (Cubicin, Cubist Pharmaceuticals) for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs).
The trial, which began in February 2014, enrolled 215 subjects, with approximately 25% in each treatment arm. The study’s primary endpoint was clinical success in the intent-to-treat population, defined as a reduction of at least 20% in the area of the ABSSSI lesion relative to baseline, when observed 48 to 72 hours after the first dose of study drug, and with no rescue antibiotics administered. This is consistent with the 2013 FDA guidance for ABSSSI studies.
All three brilacidin treatment arms (two single-dose regimens and one 3-day dosing regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable with that of the FDA-approved 7-day dosing regimen of daptomycin.
All of the brilacidin treatment regimens were well tolerated. Six severe adverse events were reported during the study, none of which was considered to be related to brilacidin by the principal investigator.
Based on these data, a pivotal phase III trial of single-dose brilacidin in ABSSSI will be conducted in 2015.
Licensed from the University of Pennsylvania, brilacidin is the first in a new class of small-molecule antibiotics known as defensin-mimetics. These antibiotics are modeled after host defense proteins, which are the “front line” of defense in the human immune system.
Data from the new phase IIb study will be presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases, to be held April 25–28, 2015, in Copenhagen, Denmark.
Sources: Cellceutix Corporation; October 23, 2014; and Brilacidin; 2014.