Policy & Regulation
Preliminary Data from BioPharmX Study Suggest Feasibility of BPX-01 1% and 2% in Patients with Rosacea
13 September 2017 - - Menlo Park, California-based specialty pharmaceutical company BioPharmX Corp. (NYSE MKT: BPMX) has released 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 company said.
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-011 is a hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that has been shown to penetrate the skin to deliver the antibiotic to its target.
Following positive results from its previously announced phase 2b study of BPX-01 in acne, BioPharmX continues with phase 3 clinical study plans for BPX-01 for the treatment of acne.
BioPharmX seeks to provide products through proprietary platform technologies for prescription, over-the-counter, and supplement applications in the health and wellness markets, including dermatology and women's health.