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BioPharmX completes acne trial enrollment

BioPharmX Corporation announced it has competed enrollment of a phase 2b dose finding clinical trial to measure the efficacy and safety of BPX-01 for treating acne vulgaris.

The OPAL (tOPicAL Minocycline Gel) study is a 12-week multi-center, double-blind, vehicle control trial of 225 individuals with moderate-to-severe inflammatory, non-nodular acne vulgaris, according to a press release.

BPX-01 is a topical minocycline gel, which delivers the drug directly to the acne source while avoiding systemic exposure to the antibiotic, BioPharmX reported.

Absolute mean change from baseline in lesion count at week 12 is the study’s primary endpoint, and results of the study will be used to guide the design of a phase 3 trial, according to the release.

 “We are pleased there is so much interest in BPX-01 and are optimistic the OPAL trial outcome will take BPX-01 one step closer to providing those who suffer from acne with an advanced treatment option,” Anna Marie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX, stated in the release. “Many in the dermatology community look forward to the results, which we expect will be available in the first half of 2017,”

Phase 2a study data showed that BPX-01 reduced acne causing bacteria by more than 90% after 4 weeks, comparable to much higher doses of oral minocycline, according to BioPharmX.