MENLO PARK, Calif., Aug. 24, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: 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.
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 safety, efficacy and projected development of BPX-01, future enrollment in the OPAL study, and timing of the OPAL study results. These forward-looking statements may be identified by words such as "will," "can," "plan," "expect," "anticipate," "believe," or the negative of these terms, and similar expressions that are intended to identify forward-looking statements. These forward-looking statements involve both known and unknown 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, including but not limited to the sufficiency of our resources and our ability to raise additional capital to continue our development programs, our ability to successfully develop and commercialize potential products such as BPX-01, as well as other risks and uncertainties associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. Such risks and uncertainties include those described in the company's filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended January 31, 2016 and our Quarterly Reports on Form 10-Q. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. All information included in this press release or cited herein is provided only as of the date hereof and the company undertakes no obligation to publicly update or revise any such statement, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
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SOURCE BioPharmX Corporation