BioPharmX has enrolled the first subject in a Phase 2b clinical trial of BPX-04, a novel topical gel formulation of minocycline for the treatment of rosacea.
The trial is a randomized, double-blind, vehicle-controlled study in subjects with inflammatory lesions of rosacea. The 12-week, multi-center study will evaluate BPX-04, a 1% topical minocycline, carried by the HyantX delivery system, a proprietary, anhydrous hydrophilic topical system developed by BioPharmX. The trial plans to enroll 176 subjects at least 18 years old with an investigator's global assessment (IGA) score of 3 or 4 (moderate or severe), and 15 to 70 inflammatory lesions on their faces at baseline. The study allows for an optional interim analysis to adjust the study's sample size.
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"Dermatologists and their patients are still searching for effective innovations in treatments for rosacea," said Neal Bhatia, M.D., director of clinical dermatology at Therapeutics Clinical Research in San Diego who was the principal investigator for the company's Proof-of-Concept (POC) trial. "The goal is to substantiate early research conclusions that suggest BPX-04 may offer the effective treatment of rosacea while minimizing the unwanted adverse effects associated with oral forms of antibiotics."
The primary endpoint for the study is an absolute mean change in the number of inflammatory lesions of rosacea from baseline to week 12. The secondary endpoint is the proportion of subjects with at least a two-grade reduction in IGA to clear (0) or almost clear (1), from baseline to week 12.
"The enrollment of our first subject represents an important milestone for BPX-04," said David Tierney, BioPharmX CEO. "We are optimistic the study will demonstrate that BPX-04 is safe, effective and easy to use, which should significantly improve patient compliance – a serious challenge to rosacea treatment."
Oral minocycline has been widely used in the treatment of skin conditions like rosacea and acne since the 1970s, but the pharmaceutical industry has not previously been able to develop a stable, topical formulation of fully solubilized minocycline, which appears to induce less resistance than other tetracycline-class antibiotics commonly used for these diseases. By applying minocycline topically, a patient will likely reduce the systemic exposure of minocycline and focus the drug's beneficial effects at the skin where they are needed most.