BioPharmX Completes Enrollment of BPX-01 Phase 2b OPAL Clinical Trial for Acne Vulgaris
Key milestone achieved for development of BPX-01, a potential advance in treatment for acne
MENLO PARK, Calif., Jan. 4, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced the on-time completion of 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.
"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," said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX. "Many in the dermatology community look forward to the results, which we expect 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 of the study will be used to guide Phase 3 trial design.
BPX-01 is the first fully solubilized, non-oily, easy-to-use topical minocycline gel capable of being delivered to the sebum-rich areas where P. acnes reside. The 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.
The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting 40 million to 50 million Americans at any given moment. The U.S. market for acne medications is estimated at $10 billion.
