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Press Release

BioPharmX Announces Final Phase 2a Trial Results Find BPX-01 Reduces Facial P. Acnes by More than 90% in Four Weeks

BioPharmX Corporation
Posted on: 22 Aug 16

PR Newswire

MENLO PARK, Calif., Aug. 22, 2016

MENLO PARK, Calif., Aug. 22, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today released final findings from its Phase 2a safety study of BPX-01 that show the unique topical gel formulation of minocycline reduced facial P. acnes by more than 90 percent after four weeks – a statistically significant advantage over the study's control vehicle.

Daily application of BPX-01 resulted in a statistically significant reduction of P. acnes at four weeks compared to baseline. The reduction at four weeks was also statistically significant between BPX-01 and the vehicle control. No adverse cutaneous effects were observed, no clinically significant hematologic or chemistry alterations occurred, and no minocycline was detected in the plasma at any timepoint.

The reduction of P. acnes was 91 percent after four weeks of using BPX-01, a significant improvement for a topical formulation.

The reduction in P. acnes achieved in the Phase 2a study is similar to that reported in a 1996 study that effectively defined oral minocycline as the superior antimicrobial to fight P. acnes1

One recognized issue with oral minocycline is that – even though it is the antibiotic most commonly prescribed for the treatment of P. acnes – it enters the patient's bloodstream and can cause unwanted side effects. The BPX-01 Phase 2a study found no detectable levels of minocycline in the bloodstream of patients using the topical minocycline.  The study also found no cutaneous toxicity and no adverse effects.

The reduction in P. acnes found during the Phase 2a study in the per protocol population is shown in the following table:

P. acnes Reduction with BPX-01 vs. Vehicle

BPX-01 1% Minocycline Topical Gel (n=17)

Vehicle Control (n=7)

Time Point

Mean % change from baseline (SD)

Log10 mean change from baseline (SD)

Mean % change from baseline

Log10 mean change from baseline (SD)

Week 4


-1.04* (0.55)


-0.46** (0.40)

*active at baseline vs. active at week 4, p<0.0001

**active at week 4 vs. vehicle at week 4, p=0.020


"This analysis of our final results suggests that BPX-01 can be effective in the reduction of P. acnes – but at a much lower, safer dose than is common with oral minocycline, the standard of care," said Anja Krammer, president and co-founder of BioPharmX. "We are excited to begin our Phase 2b study and optimistic it will confirm the effectiveness of this product."

BPX-01 is the first topical gel formulation of minocycline that can penetrate the skin to deliver the antibiotic to the site of acne development in the pilosebaceous unit. BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline.

The BPX-01 Phase 2a study randomized subjects to once daily treatment with BPX-01 1% minocycline topical gel or a vehicle control. The study's patient exit survey indicated 100 percent satisfaction with BPX-01's usability and tolerability.

"The dermatology community is excited about the promise of BPX-01," said Dr. Hilary Baldwin, a board-certified dermatologist with nearly 25 of years of experience and co-chair of the BioPharmX Therapeutic Dermatology Medical Advisory Board. "We would love to have an effective topical treatment that fights P. acnes without exposing patients to the risk of systemic antibiotics."

The American Academy of Dermatology calls acne the "most common skin condition 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 dermatology and women's health. To learn more about BioPharmX, visit          

Forward-Looking Statement
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 the safety, efficacy and projected development of BPX-01. 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.

BioPharmX is a registered trademark of BioPharmX, Inc.

1 The antimicrobial effects in vivo of minocycline, doxycycline and tetracycline in humans. Leyden JJ, Kaidbey K & Gans EH. Journal of Dermatological Treatment (1996) 7, 223- 225.

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SOURCE BioPharmX Corporation

PR Newswire

Last updated on: 22/08/2016

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