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
Jan 4, 2017
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.
About BioPharmX® Corporation
BioPharmX Corporation (NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical company that seeks to provide products through proprietary platform technologies for prescription, over-the-counter and supplement applications in the health and wellness markets, including dermatology and women's health. To learn more about BioPharmX, visit www.BioPharmX.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements about the company's expectations, plans, intentions and strategies, including, but not limited to, statements regarding whether topical minocycline is effective in fighting inflammation caused by acne vulgaris, and the results and timing of the Phase 2b OPAL trial. These forward-looking statements may be identified by words such as "plan", "expect," "anticipate," "believe," or similar expressions that are intended to identify such forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The risks and uncertainties include those described in the company's filings with the Securities and Exchange Commission. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements included in this news release are made only as of the date hereof and the company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
SOURCE BioPharmX Corporation
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