BioPharmX has reported positive results from its Phase IIb trial of BPX-041 for the treatment of moderate-to-severe papulopustular rosacea, a chronic dermatologic condition characterised by redness, stinging and inflammatory lesions primarily on the face.
The company enrolled the first subject in October last year to study BPX-04, a novel topical gel formulation of fully solubilised minocycline and a 1% minocycline gel.
The randomised, double-blind, vehicle-controlled Phase IIb trial has successfully met both the primary and secondary endpoints.
A statistically significant mean change in the number of facial inflammatory lesions and a two-grade improvement to clear or almost clear was observed on the Investigator's Global Assessment (IGA) scale from baseline to week 12.
BioPharmX CEO Dr David Tierney said: "We are extremely pleased with the positive outcome on both the primary and secondary efficacy measures, as well as the confirmation of the safety and cutaneous tolerability of our minocycline gel formulation.
“We view these results as further affirmation of the benefits of BioPharmX's proprietary HyantX delivery system. Based on the efficacy and safety profile, we believe BPX-04 has the potential to be the best-in-class treatment for papulopustular rosacea.”
For the trial, a total of 206 patients aged 18 years and above with moderate-to-severe papulopustular rosacea were enrolled across 11 sites in the US to evaluate the safety and efficacy of a once daily application of BPX-04 versus a vehicle control for a treatment period of 12 weeks.
During the study, BPX-04 was administered using BioPharmX’s HyantX delivery system and appeared to be generally well-tolerated.
The HyantX topical delivery system is an anhydrous hydrophilic gel formulation, designed for the absorption of active pharmaceutical ingredients into the skin.