BioPharmX (BPMX) Announces First Subject Enrolled in OPAL Phase 2b Trial of BPX-01

August 24, 2016 8:03 AM EDT
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BioPharmX Corporation (NYSE: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced that the first subject has been enrolled in its Phase 2b clinical trial assessing the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The study is formally known as the OPAL (tOPicAL Minocycline Gel) study.

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. This unique topical formulation delivers drug directly to the source of acne while avoiding systemic exposure. Findings from the Phase 2a safety study of BPX-01 showed the BPX-01 topical gel formulation of minocycline eliminated more than 90% of acne-causing bacteria after four weeks – effectiveness comparable to that with much higher doses of oral minocycline.

"We are optimistic the OPAL trial will confirm the safety and efficacy of BPX-01 as a breakthrough acne treatment," said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs. "Initiation of this study marks an important milestone for not only the company, but the millions of acne patients who have been underserved by currently available therapies."

The 12-week, multi-center, double-blind, three-arm, vehicle controlled OPAL study expects to enroll 225 people, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris.

Safety will be assessed by physical examination, clinical laboratory tests, cutaneous tolerance scores and incidence of adverse events.

The primary efficacy endpoint for the study is mean change from baseline in inflammatory lesion counts at Week 12. The secondary efficacy endpoint is achievement of at least a two-grade reduction in Investigator Global Assessment (IGA) at Week 12 compared to baseline.

The company expects results from the OPAL study in the first half of 2017.

"This trial is exciting for the dermatology community because the current standard of care for acne often exposes patients to systemic antibiotics," said Joely Kaufman, a board certified dermatologist at The Skin Research Institute in Miami and fellow of the American Academy of Dermatology and principal investigator of the OPAL study. "BPX-01 has the potential to significantly improve acne patients' outcomes without common side effects in a way that no other acne medications have been able to do."

The American Academy of Dermatology calls acne the "most common skin problem in the United States," affecting 40 to 50 million Americans. The U.S. market for acne medications is estimated at $10 billion.

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