BioPharmX granted CARC waiver by FDA for acne candidate BPX-01
BioPharmX announced that the FDA has waived its requirement for a dermal carcinogenicity study for BPX-01, eliminating several years of non-clinical research normally required for FDA review. BPX-01, a novel topical gel formulation of minocycline for the treatment of inflammatory acne, received the waiver based on the results of a 39-week dermal minipig toxicity study conducted by BioPharmX and the extensive safety history of minocycline products including the clinical safety data from the BPX-01 Phase 2 acne studies. The 39-week minipig study with BPX-01 found no pre-neoplastic or hyperplastic changes that might be indicative of carcinogenic potential and the clinical studies were also negative in terms of cutaneous toxicity. The company also released a post hoc analysis of phase 2b data assessing the impact of BPX-01 on the treatment of acne vulgaris in women. It found that female subjects outperformed the overall study population in the Investigator Global Assessment outcomes. A higher proportion of subjects in the female subgroup demonstrated a clinically relevant improvement in acne severity.