BPX-01 topical minocycline shows efficacy in treating acne

BioPharmX announced that BPX-01 showed efficacy in both 1% and 2% doses in treating moderate-to-severe acne in children and adults.

BPX-01 is a solubilized topical minocycline gel product candidate for the treatment of moderate-to-severe acne. In meeting a phase 2b study’s primary endpoint, both 1% and 2% doses of BPX-01 significantly reduced non-nodular inflammatory acne lesions when compared to vehicle, according to a news release from BioPharmX.

The randomized, double-blind study measured the efficacy and safety of BPX-01 in two concentrations and vehicle in treating 226 patients, aged 9 to 40 years, with moderate-to-severe inflammatory, non-nodular acne vulgaris.

The BPX-01 2% treatment cohort (n = 72) had a reduction of 15.4 in absolute mean change in number of acne lessons at week 12 compared to baseline (P = 0.022 compared to vehicle), while the BPX-01 1% cohort (n = 73) had a reduction of 15.5 compared to baseline (P = .037 compared to vehicle) and vehicle cohort (n = 74) had a reduction of 11.3 compared to baseline.

The study’s secondary endpoint was the proportion of patients with at least a two-grade reduction in Investor’s Global Assessment to clear “0” or almost clear “1.” In the BPX-01 2% cohort, 22.7% met the secondary endpoint, while 16% of the BPX-01 1% cohort and 17.1% of vehicle also met the secondary endpoint. However, the results were not statistically significant.

BioPharmX has not yet analyzed the safety data from the phase 2b study, but there were no serious adverse events related to study treatment reported to the company by the investigators, according to the release.

Reference: www.biopharmx.com