Given the clinical development of BPX-01 for the treatment of acne and the similarities between acne and rosacea, BioPharmX is also pursuing development of its topical minocycline gel in the indication for rosacea. We are currently evaluating BPX-04 in an open-label study consisting of up to 30 subjects with moderate-to-severe papulopustular rosacea. The study uses a 12-week, once-daily treatment using BPX-01 1% and 2% minocycline and vehicle.
Preliminary data from the ongoing study suggest good tolerability and promising efficacy of BPX-04 in rosacea and highlight the value of our anhydrous hydrophilic topical delivery system.
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.
Based on these results, the company expects to pursue additional research to evaluate the efficacy of BPX-04 in rosacea.
ROSACEA – The National Rosacea Society describes rosacea as a common, but poorly understood disorder of the facial skin that affects an estimated 16 million Americans, many of whom do not even know they have the condition. Rosacea is characterized by facial redness, pimples, bumpy breakouts, and thickening of the skin. The condition can also affect the eyes by causing dry eyes and blurred vision.