BioPharmX (BPMX) Announces Statistically Significant Data from BPX-01 Phase 2a

August 22, 2016 8:03 AM EDT
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BioPharmX Corporation (NYSE: BPMX) 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.

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