BioPharmX Corporation’s topical minocycline for acne, BPX-01, achieved its primary endpoint in a phase 2b clinical trial.
There were statistically significant reductions in non-nodular inflammatory acne lesions when compared to vehicle in both the 1 percent and 2 percent doses of BPX-01, the topline results show.
BioPharmX continues to progress BPX-01 towards a phase 3 program based on these phase 2b results.
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. It 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. While this trial was not powered for statistical significance for IGA, this endpoint was included to inform the design of the pivotal phase 3 program.
The company has not yet analyzed the safety data from the phase 2b study. There were no serious adverse events related to study treatment reported to the company by the investigators during the trial.
BioPharmX will present comprehensive results from the phase 2b study at an event for the investment community in New York next month. The company also plans to submit the data for presentation at an upcoming medical conference and for publication in a peer-reviewed medical journal.