BioPharmX achieves primary endpoint in its phase 2b Clinical Trial evaluating BPX-011

On May 4, 2017

BioPharmX announced that it achieved primary endpoint in its phase 2b clinical trial evaluating BPX-011.

From the topline results for the study’s primary endpoint, BioPharmX observed in both the 1 percent and 2 percent doses of BPX-01 statistically significant reductions in non-nodular inflammatory acne lesions when compared to vehicle. The absolute mean change in the number of acne lesions from baseline to week 12 for each arm was

BPX-01 2% (n=72), a reduction of 15.4 compared to baseline (p=0.022 compared to vehicle)
BPX-01 1% (n=73), a reduction of 15.5 compared to baseline (p=0.037 compared to vehicle)
Vehicle (n=74), a reduction of 11.3 compared to baseline

The phase 2b study was a randomized, double-blind, three-arm, vehicle-controlled dose-finding study to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The multi-center study evaluated two concentrations of BPX-01 (1% and 2% minocycline) and vehicle in 226 subjects, aged 9 to 40, with moderate-to-severe inflammatory, non-nodular acne vulgaris.

The phase 2b study also measured reduction in Investigator’s Global Assessment (IGA) as a secondary endpoint. This secondary endpoint was defined as the proportion of subjects with at least a two-grade reduction in IGA to clear “0” or almost clear “1.” The proportion that achieved this endpoint was 22.7 percent for BPX-01 2%, 16.0 percent for BPX-01 1%, and 17.1 percent for vehicle. Although these secondary endpoint results were not statistically significant, BioPharmX observed in the BPX-01 2% arm a clear numerical trend compared to vehicle.

Based on these phase 2b results, BioPharmX continues to progress BPX-01 towards a phase 3 program.

BioPharmX co-founder and president, Anja Krammer said that these results represent a major milestone for the company and offer the potential of BPX-01 as the first topical gel minocycline for moderate-to-severe acne, optimizing safety and efficacy of a proven antibiotic for this condition to millions of patients. They look forward to sharing detailed phase 2b data with the investor and medical communities over the coming months.