BioPharmX Announces Preliminary Data from Rosacea Feasibility Study
Data suggest feasibility of BPX-01 1% and 2% in patients with rosacea
MENLO PARK, Calif. Sept. 12, 2017 – BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company focusing on dermatology, is announcing preliminary data from a feasibility study of BPX-01 to assess the safety and efficacy of topical minocycline gel at both the 1% and 2% doses for the treatment of rosacea. The preliminary data from the ongoing study suggest good tolerability and promising efficacy of BPX-01 in this indication and highlight the value of BioPharmX’s dermatology delivery system.
This ongoing 12-week, open-label feasibility study to assess the safety and efficacy of BPX-01 topical minocycline gel in rosacea patients enrolled 20 subjects with moderate-to-severe papulopustular rosacea, who applied BPX-01 once daily. Safety was assessed by reviewing treatment emergent adverse events, shifts from baseline in hematology and chemistry laboratory tests as well as cutaneous tolerance scores as assessed both by study subjects and investigators. The preliminary data show that BPX-01 was well tolerated in all subjects treated to date. No adverse events were determined to be treatment related and there were no clinically significant shifts from baseline in hematology and chemistry laboratory tests.
The primary efficacy endpoint from this study is change in Investigator’s Global Assessment (IGA) of rosacea at 12 weeks. The secondary efficacy endpoint is change in facial lesion count from baseline at 12 weeks. The preliminary data obtained to date suggest a positive effect on rosacea lesions. Of the 15 subjects that have completed 12 weeks of treatment in the study, 100% have IGA scores of clear (0) or almost clear (1), compared to their baseline scores of moderate (3) or severe (4). Investigators also observed a 93% reduction in total inflammatory lesions from baseline to week 12 in the same subjects who have completed the 12-week study.
“BPX-01 has been well tolerated by the study subjects,” said Dr. Neal Bhatia, a board-certified dermatologist at Therapeutics Clinical Research who is the study’s principal investigator. “We are pleased with the initial data on efficacy. We look forward to the final results of the study and determining next steps.”
Company executives said they expect to pursue additional research to evaluate the efficacy of BPX-01 in rosacea.
“These preliminary results are encouraging and give us guidance as we evaluate our clinical development plan for rosacea. They also reinforce the potential value of our unique drug delivery platform across various dermatology indications,” said Anja Krammer, president of BioPharmX. “Additionally, we are excited by the prospect that it may offer rosacea patients a long-overdue therapeutic innovation.”
