BioPharmX Receives Concurrence from FDA on Phase 3 Acne Study Plans

BioPharmX has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding design of its planned phase 3 clinical trial for BPX-011, the company's topical minocycline gel for the treatment of inflammatory lesions of acne vulgaris.

The company has incorporated feedback from the FDA on key elements of its phase 3 acne program and received clear guidance regarding expectations and requirements for clinical, non-clinical, and chemistry, manufacturing and controls (CMC) needed to support a post phase 3 NDA submission.

Consistent with oral minocycline products, BPX-01 is intended for the targeted treatment of non-nodular inflammatory acne vulgaris. Therefore, BioPharmX believes that an Investigator's Global Assessment (IGA) scale specific to inflammatory lesions is the most appropriate IGA scale to measure treatment success in the co-primary efficacy endpoint as described in the 2005 guidance document for acne product development. The FDA concurred with the company's proposal to use an inflammatory lesion IGA as a co-primary endpoint along with inflammatory lesion reduction.

In light of this positive feedback from the FDA, the company continues to consider various options as it finalizes its study design plans and works on additional program requirements needed for an NDA submission. The company is considering strategic partnering alternatives to fund its phase 3 acne clinical trials and expects to begin the trial, should the company raise the necessary capital or upon entering into a strategic partnership to fund the trials.

"We are extremely pleased to reach agreement with the FDA on our proposed endpoints and believe that this could allow the company to move towards a strategic partnership that will fund our phase 3 program and advance our novel topical gel acne product towards commercialization," said Anja Krammer, president of BioPharmX. "We further believe that agreement on these endpoints could help us better achieve positive clinical trial results, and enter the market with a compelling product for the treatment of inflammatory acne."

BPX-011 is a hydrophilic (non-oil-based) topical gel with fully solubilized minocycline that has been shown to penetrate the skin to deliver the antibiotic to its target. Following positive results from its previously announced phase 2b dose range study of BPX-01 in acne, BioPharmX continues with phase 3 clinical study plans for BPX-01 for the treatment of inflammatory lesions of acne.