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."
The comprehensive study results will be presented today at a "State of Acne" symposium in New York City.
The symposium will feature presentations from preeminent dermatology thought leaders, including principal investigators in the phase 2b study of BPX-01.
Speakers scheduled to present at the event include:
Hilary Baldwin, M.D., SUNY; Medical Director, Acne Treatment & Research Center in New York City
Jim Leyden, M.D., Professor Emeritus of Dermatology, University of Pennsylvania
Scott Herron, M.D., Ph.D., Medical Director, BioPharmX
Neal Bhatia, M.D., Therapeutics Clinical Research, San Diego
Andrew Alexis, M.D., Chairman, Department of Dermatology at Mount Sinai System in New York City
Ted Lain, M.D., Board-certified dermatologist, Austin, Texas
BioPharmX will present its comprehensive results at the symposium at 8:30 a.m. ET. The event will be (both) webcast live and archived for 90 days at http://www.biopharmx.com/media/#events.
Summary of phase 2b data in link.
http://www.prnewswire.com/news-releases/bioph...66935.html
- 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."
The comprehensive study results will be presented today at a "State of Acne" symposium in New York City.
The symposium will feature presentations from preeminent dermatology thought leaders, including principal investigators in the phase 2b study of BPX-01.
Speakers scheduled to present at the event include:
Hilary Baldwin, M.D., SUNY; Medical Director, Acne Treatment & Research Center in New York City
Jim Leyden, M.D., Professor Emeritus of Dermatology, University of Pennsylvania
Scott Herron, M.D., Ph.D., Medical Director, BioPharmX
Neal Bhatia, M.D., Therapeutics Clinical Research, San Diego
Andrew Alexis, M.D., Chairman, Department of Dermatology at Mount Sinai System in New York City
Ted Lain, M.D., Board-certified dermatologist, Austin, Texas
BioPharmX will present its comprehensive results at the symposium at 8:30 a.m. ET. The event will be (both) webcast live and archived for 90 days at http://www.biopharmx.com/media/#events.
Summary of phase 2b data in link.
http://www.prnewswire.com/news-releases/bioph...66935.html
