BioPharmX released comprehensive phase 2b clinical data showing that its investigational acne drug BPX-01 2% reduces the number of inflammatory lesions in acne patients by 59% versus 44% in vehicle with no serious drug-related adverse side effects experienced– and suggesting it may also lessen the severity of lesions.
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 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 (59% vs. 44% at week 12).
The phase 2b study also measured reduction in a five-point investigator's global assessment (IGA) scale. The percentage of subjects treated with BPX-01 2% who showed at least a two-grade improvement and an IGA of clear or almost clear, a secondary efficacy endpoint in the study was 25 percent. Although these secondary endpoint results were not statistically significant, BioPharmX observed in the BPX-01 2% arm a clear numerical trend compared to vehicle. The phase 2b research was not powered to measure IGA statistical significance. Because IGA will be a required co-primary endpoint in phase 3, the study will be powered to measure statistical significance of IGA with at least a two-grade improvement and a score of clear or almost clear.
Researchers also found that no subjects experienced serious treatment-related adverse side effects. A PK study showed that plasma minocycline levels following topical use were undetectable in all but a single subject, whose level – 42 ng/mL – was one-tenth of that measured after a standard adult dosage of oral minocycline.
BPX-01 is the first hydrophilic topical gel with fully solubilized minocycline that can penetrate the skin to deliver the antibiotic to where acne develops in the pilosebaceous unit. It is designed for the treatment of moderate-to-severe acne.