Specialty pharmaceutical company BioPharmX announced topline results from its Phase 2a safety study of BPX-01, a hydrophilic topical gel formulation of solubilized minocycline. The results showed the product reported no cutaneous toxicity and resulted in no adverse effects. The study also revealed that the gel left no detectable levels of minocycline in the patients’ bloodstreams, which suggests that a much lower dose of minocycline applied topically has the potential to treat acne without the side effects normally associated with the oral form of the antibiotic.
The randomized study involved 30 subjects who underwent once daily treatment with BPX-01 1% minocycline topical gel or a vehicle control. A statistically significant reduction in P. acnes was observed after four weeks of BPX-01 treatment compared to baseline. The patient exit survey indicated 100% satisfaction with usability and tolerability.
“The findings confirm the data from preclinical studies of BPX-01 and reaffirm our belief that BPX-01 has the potential to revolutionize the way dermatologists treat acne,” said Anja Krammer, president and co-founder of BioPharmX. “These positive Phase 2a results allow us to proceed with next phase clinical studies with BPX-01 and we are optimistic that the planned Phase 2b study will further confirm the value of this product.”
BioPharmX expects to begin enrollment of its Phase 2b study by the end of summer.