BPX-01 2% reduced acne lesions by 59%

BioPharmX Corporation announced comprehensive phase 2b clinical data results that showed BPX-01 2% reduced the number of inflammatory lesions in acne patients by 59% compared with 44% in vehicle, while also suggesting it may lessen the severity of lesions.

The multi-center phase 2b study evaluated two concentrations of BPX-01 (1% and 2% minocycline) and vehicle in 226 people, aged 9 to 40 years, with moderate-to-severe inflammatory, non-nodular acne vulgaris. BPX-01 is an investigational hydrophilic topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit, according to a news release.

The study showed the 2% concentration was statistically superior in reducing the number of inflammatory lesions in patients with moderate-to-severe acne, compared to vehicle at week 12, according to the release.

The five-point investigator’s global assessment (IGA) scale also was measured, with 25% of patients treated with BPX-01 2% showing at least a two-grade improvement and an IGA of clear or almost clear, a secondary efficacy endpoint in the study. The results were not statistically significant; however, a clear numerical trend was observed in the BPX-01 2% arm a clear numerical trend compared to vehicle, according to the release.

While the phase 2b study was not powered to measure IGA statistical significance, IGA will be a required co-primary endpoint in a phase 3 study, BioPharmX announced.

There were no serious treatment-related adverse events reported.

"We are very pleased about the initial efficacy we are seeing in lesion reduction with BPX-01 2% and look forward to end-of-phase 2 discussions with the [FDA]," Anja Krammer, co-founder and president of BioPharmX, stated in the release.

The phase 2B study results were presented at a "State of Acne" symposium in New York City. which included principal investigators of the study.

Reference: www.biopharmx.com