The FDA has waived its requirement for a dermal carcinogenicity study for BPX-01 from BioPharmX Corporation, 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. Based on these data, FDA agreed that no new useful information was likely to be gained by additional non-clinical animal studies.

“The FDA waiver is important because it shaves years off of our non-clinical research, accelerating our regulatory schedule and eliminating concerns about the added time and costs of our non-clinical development,” said AnnaMarie Daniels, BioPharmX executive vice president of clinical and regulatory affairs. “Our minipig study confirmed years of prior research showing that our BPX-01 topical minocycline poses no new carcinogenic threat to humans.”

BioPharmX also has 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 (IGA) outcomes.

The Phase 2b clinical trial (ITT=219) was a 12-week randomized, double-blind, vehicle-controlled, dose-ranging study to assess the safety and efficacy of BPX-01 minocycline topical gel in the treatment of moderate to severe inflammatory acne vulgaris. Relative to the total ITT population, a higher proportion of subjects in the female subgroup (N=149) demonstrated a clinically relevant improvement in acne severity. In female subjects with a baseline IGA score of 3 or 4 (moderate-to-severe), 29.2% achieved a two-grade reduction to clear or almost clear while 25% of the total ITT population achieved this reduction. In female subjects with a baseline IGA score of 3 (moderate only), 31.8% of subjects achieved a two-grade reduction to clear or almost clear.

"The results from the female subgroup analysis of BPX-01 in the Phase 2b acne trial is very relevant, and offers promise to a large patient population suffering from acne,” said Hilary Baldwin, Medical Director of the Acne Treatment & Research Center in Morristown, NJ, and co-chair of the BioPharmX Medical Advisory Board. “There is a significant need for a product that offers not only efficacy, but just as importantly, cosmetic elegance for women whose treatment options must fit their lifestyles and skin care regimens."

The analysis will be presented at the Dermatology Education Foundation’s DERM2018 conference in a poster entitled “Subset Analysis of IGA in Female Demographic in BPX-01 Topical Minocycline Gel Phase 2b Trial for the Treatment of Inflammatory Acne Vulgaris,” this month in Las Vegas.

BPX-01 uses the novel, patented HyantX™ delivery system, which stabilizes and solubilizes hydrophilic molecules in an anhydrous gel environment. This delivery system is capable of carrying a variety of active ingredients—and even combinations of actives—into the skin.  Research has shown the delivery system may allow for maximum solubility for multiple actives, which is intended to lead to enhanced skin penetration and increased efficacy and tolerability, has antibacterial properties, and hydrates the skin, making the delivery system a valuable asset in pipeline development and strategic partnering.

BioPharmX continues to be in ongoing discussions with a number of potential strategic partners regarding interest in the company’s BPX-01 product candidate for the treatment of acne. The company continues to assess several written indications of interest and is evaluating the variety of financial and strategic benefits of the various options. Management remains diligent and deliberate in its thoughtful consideration of options as it works to maintain the best interests of the company and its shareholders.