BioPharmX to Present Phase 2b Clinical Trial Acne Data at Alabama Dermatology Society Summer Symposium
BPX-01 2% formulation reduced inflammatory lesions by 59%
25% of subjects achieved two-grade IGA reduction (to clear/almost clear)
86% of subjects said they would use BPX-01 again
Presentation to be held Friday at 10 a.m. CDT
MENLO PARK, Calif., June 22, 2017 /PRNewswire/-- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company focusing on dermatology, will present results of its phase 2b of BPX-01, a unique topical hydrophilic gel formulation of minocycline, at the Alabama Dermatology Society's Summer Symposium being held June 22-25 in Sandestin, Fla.
Findings from the phase 2b will be discussed during the presentation "Acne Vulgaris: What Do Available and Newer Therapies Bring to the Table?" by Dr. James Q. Del Rosso, founder of JDR Dermatology Research, Las Vegas. His presentation is scheduled for 10 a.m. Friday.
The company's poster presentation, entitled "Results from a Randomized, Double-Blind, Vehicle-Control Study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate-to-Severe Inflammatory Acne Vulgaris," will take place at 7:00 p.m. CDT today.
Phase 2b data showed the 2% formulation of BPX-01 reduced acne lesions in subjects by 59% (compared to 44% for vehicle) and delivered at least a two-grade reduction in investigator global assessment (IGA) and clear to almost clear for 25% of subjects. The Phase 2b research was not powered to measure IGA statistical significance. The study found BPX-01 was generally well tolerated, without any serious drug-related adverse events experienced, no photosensitivity, staining or skin discoloration.
While BioPharmX previously presented phase 2b data to the investor community, the Symposium will be the first time it shares the research in a medical conference. It will also be the first time the medical community hears research showing that subjects had a positive experience with BPX-01. A survey of subjects at week 12 found that 79% thought BPX-01 2% was easy to use and apply. 86% said they would use BPX-01 2% again.
"Efficacy and safety are crucial to dermatologists and their acne patients, but just as important is patient compliance," said G. Scott Herron, M.D., Ph.D., BioPharmX Medical Director, board-certified dermatologist and fellow of the American Academy of Dermatology. "Medicines that are easy to use improve compliance. Phase 2b subjects told us BPX-01 is easy to use and they expressed a willingness to use it again. We believe this gives BPX-01 a significant advantage over topical therapies that have irritating side effects like rashes, dryness or itching, or oral therapies that are associated with headaches, dizziness or diarrhea."
BPX-01 is the first topical gel formulation of minocycline that can penetrate the skin to deliver the antibiotic to the pilosebaceous unit, where acne develops. It is also the first and only stable hydrophilic and non-oil-based topical gel with fully solubilized minocycline. The company's studies are designed to confirm whether BPX-01 will effectively treat acne with lower dosages of the antibiotic with no or fewer adverse side effects.
The American Academy of Dermatology calls acne the "most common skin condition in the United States," affecting up to 50 million Americans. The disease can cause permanent scarring, low self-esteem, depression and anxiety.
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