BioPharmX Corp fka BPMX

[Whos_Who]

BioPharmX Phase 2b Study Recap

BioPharmX Advances BPX-01 2% Upon Achieving Statistical Significance for Primary Endpoint

Phase 2b study demonstrates 59% reduction in number of acne lesions using BPX-01 2% vs. 44% in vehicle

- Data show BPX-01 is generally well tolerated

MENLO PARK, Calif., June 1, 2017 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX) today released comprehensive phase 2b clinical data showing that its investigational acne drug BPX-01 2% reduces the number of inflammatory lesions in acne patients by 59% versus 44% in vehicle with no serious drug-related adverse side effects experienced– and suggesting it may also lessen the severity of lesions.

The phase 2b study was a randomized, double-blind, three-arm, vehicle-controlled, dose-finding study to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The multi-center study evaluated two concentrations of BPX-01 (1% and 2% minocycline) and vehicle in 226 subjects, aged 9 to 40, with moderate-to-severe inflammatory, non-nodular acne vulgaris. The study showed the 2% concentration was statistically superior in reducing the number of inflammatory lesions in patients with moderate-to-severe acne, compared to vehicle (59% vs. 44% at week 12).

The phase 2b study also measured reduction in a five-point investigator's global assessment (IGA) scale. The percentage of subjects treated with BPX-01 2% who showed at least a two-grade improvement and an IGA of clear or almost clear, a secondary efficacy endpoint in the study was 25 percent. Although these secondary endpoint results were not statistically significant, BioPharmX observed in the BPX-01 2% arm a clear numerical trend compared to vehicle. The phase 2b research was not powered to measure IGA statistical significance. Because IGA will be a required co-primary endpoint in phase 3, the study will be powered to measure statistical significance of IGA with at least a two-grade improvement and a score of clear or almost clear.

Researchers also found that no subjects experienced serious treatment-related adverse side effects. A PK study showed that plasma minocycline levels following topical use were undetectable in all but a single subject, whose level – 42 ng/mL – was one-tenth of that measured after a standard adult dosage of oral minocycline.

"The results of this research are encouraging and offer promise to millions of patients suffering from moderate-to-severe acne, and to their dermatologists, who have long wanted additional effective topical alternatives to oral antibiotics," said Dr. Ted Lain, board-certified dermatologist and an investigator in the BPX-01 study.

BPX-01 is the first hydrophilic topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit. It is designed for the treatment of moderate-to-severe acne.

"We are very pleased about the initial efficacy we are seeing in lesion reduction with BPX-01 2% and look forward to end-of-phase 2 discussions with the Food and Drug Administration," said Anja Krammer, co-founder and president of BioPharmX. "We believe BPX-01 2% offers a potential opportunity to bring to market a much-needed alternative for the treatment of moderate-to-severe acne."

Summary of phase 2b data

Primary - Inflammatory Lesions
In the phase 2b study, the 2% concentration achieved statistical significance for its reduction in inflammatory lesion count at week 12, the primary endpoint, as well as inflammatory lesion reduction percentage. The 1% concentration was not statistically significant on the primary endpoint of lesion count reduction or lesion reduction percentage. Analysis reflects the intent to treat (ITT) population of 219 and imputation for the last observation carried forward (LOCF) was applied.


Complete Summary of phase 2b data in link
https://www.prnewswire.com/news-releases/biopharmx-advances-bpx-01-2-upon-achieving-statistical-significance-for-primary-endpoint-300466935.html