BPX04 is a topical antibiotic gel with fully solubilized minocycline, also leveraging our HyantX delivery system, for the treatment of papulopustular rosacea. We have completed a 30 subject, single center, open‑label feasibility study of BPX04 to assess the safety and cutaneous tolerability of BPX04 at 0% (vehicle), 1% and 2% minocycline for the treatment of moderate-to-severe papulopustular rosacea. In this study, no serious adverse events were observed and the treatment-related adverse events were related to dermal irritation in the 2% minocycline treatment arm. As cutaneous tolerability of a topical therapy is a significant driver in patient compliance, we are encouraged that 90% of cutaneous tolerability signs or symptoms were “none” or “mild” at Week 12.
The directional efficacy data collected for the 1% dose also showed promise. Given these results, we initiated a randomized, double-blind, vehicle-controlled Phase 2b study in subjects at least 18 years old with 15 to 70 inflammatory lesions with no more than 2 nodules and an IGA score of 3 or 4 (moderate or severe) at baseline. The trial has enrolled 207 subjects. The primary endpoint for this Phase 2b study is an absolute mean change in the number of inflammatory lesions. We anticipate announcing topline efficacy and safety results in July 2019.
A small, open-label study with BPX-04 showed early onset of efficacy in 1% and 2% minocycline gel for the treatment of rosacea. BPX-04 reinforces the value of the unique hydrophilic delivery system BioPharmX has developed in-house.
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.