BioPharmX Corporation completed enrollment in the OPAL (tOPicAL Minocycline Gel) study, a Phase 2b dose finding clinical trial to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris.
The 12-week, multi-center, randomized, double-blind, three-arm, vehicle-controlled OPAL study involves 225 individuals, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris. The company anticipates the results will be available in the first half of 2017.
The study's primary endpoint is absolute mean change from baseline in inflammatory lesion counts at week 12. The secondary endpoint is the proportion of subjects with at least a two-grade reduction in Investigator's Global Assessment at week 12. Results will be used to guide Phase 3 trial design.
BPX-01’s novel topical formulation delivers drug directly to the source of acne while avoiding systemic exposure to antibiotic. BPX-01 Phase 2a study data showed the unique topical gel formulation of minocycline reduced acne-causing bacteria by more than 90 percent after four weeks – effectiveness comparable to much higher doses of oral minocycline.