Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications, is pleased to announce positive top-line results for its Phase 2b randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The trial, which began in February, enrolled 215 subjects, with approximately 25% in each treatment arm. The primary endpoint was clinical success in the intent-to-treat population, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug, and no rescue antibiotics administered. This is consistent with the 2013 Food and Drug Administration (FDA) guidance for ABSSSI studies and is the same endpoint used in recent approvals for ABSSSI drugs.
All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator.
Based upon the data, Cellceutix has decided that a pivotal Phase 3 trial in 2015 will be for a single-dose of Brilacidin for ABSSSI.
Brilacidin is the first in a novel class of antibiotics known as defensin-mimetics being developed by Cellceutix. The platform is being used to develop other anti-infective drugs to address areas of high medical need, such as antibiotics for the treatment of resistant Gram-negative infections and fungal infections.
“This is an historic event and a proud day for Cellceutix shareholders as we have proven the efficacy of one dose of our novel drug Brilacidin to be comparable to seven days of therapy with the blockbuster antibiotic daptomycin to treat ABSSSI with zero drug-related SAEs,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix. “The implications to the results of the trial are broad reaching and create a tremendous opportunity for our infectious disease division. Because Brilacidin is a novel compound with a unique mechanism of action that can be administered as a single-dose, the potential for the development of resistance is very minimal, if at all, which we believe gives it a competitive edge over any approved antibiotic. The results further validate the potential for our extensive defensin-mimetic franchise as a platform for countless drug-resistant indications, aligning us in what we believe is a prime position to become a leader in anti-infective market.”
Cellceutix is preparing a poster on the completed Phase 2b clinical trial for presentation at the 25th European Congress of Clinical Microbiology and Infectious Diseases, which will be held from April 25 – 28, 2015 in Copenhagen, Denmark.