Efficacy and safety profile support advancement into Phase 3.

BioPharmX Corporation ‘s BPX-04, a novel topical gel formulation of fully solubilized minocycline for the treatment of moderate-to-severe papulopustular rosacea, performed well in a Phase 2b clinical trial, the Company reports.

In the trial, BPX-04, a 1% minocycline gel, successfully met both the primary and secondary endpoints of the trial in demonstrating a statistically significant mean change in the number of facial inflammatory lesions and a two-grade improvement to clear or almost clear on the Investigator's Global Assessment (IGA) scale from baseline to week 12.

"We are extremely pleased with the positive outcome on both the primary and secondary efficacy measures as well as the confirmation of the safety and cutaneous tolerability of our minocycline gel formulation. We view these results as further affirmation of the benefits of BioPharmX's proprietary HyantX delivery system," says Dr. David S. Tierney, BioPharmX CEO, in a news release. "Based on the efficacy and safety profile, we believe BPX-04 has the potential to be the best-in-class treatment for papulopustular rosacea."

"My patients were extremely pleased with their participation in this clinical trial. While the topline results highlight the impressive efficacy of BPX-04, the most compelling takeaway from my experience was my patient's satisfaction with BioPharmX's elegant gel formulation and the lack of irritation that is so commonly experienced with many topical agents. I look forward to the advancement of this promising topical therapy," says Mark Amster, MD a Brighton MA-based dermatologist and investigator in the clinical trial

Study Details

The randomized, double-blind, vehicle-controlled Phase 2b trial enrolled 206 subjects aged 18 years and above with moderate-to-severe papulopustular rosacea across 11 sites in the United States. The study evaluated the safety and efficacy of once daily application of BPX-04 versus a vehicle control over a 12-week treatment period. The study was designed to demonstrate a statistically significant mean change in the number of facial inflammatory lesions from baseline to week 12. The secondary endpoint, the proportion of subjects with a two-grade improvement to clear or almost clear on the IGA scale from baseline to week 12, was included to collect sufficient data to design a Phase 3 program with co-primary efficacy endpoints, however, as is standard in a Phase 2 trial, the study was not designed to demonstrate statistical significance on the secondary endpoint.

Baseline Severity

The mean inflammatory lesion count at baseline was 23.9 and 24.0 for the BPX-04 and vehicle treatment groups, respectively.

The proportion of subjects with an IGA score of 3 ("moderate") and 4 ("severe") at baseline was 92.7 percent and 7.3 percent for the BPX-04 treatment group, respectively, and 91.1 percent and 8.9 percent for the vehicle treatment group, respectively.

Efficacy Assessments

BPX-04 demonstrated a statistically significant improvement from baseline. In addition to meeting the primary and secondary endpoints of the trial, BPX-04 demonstrated a statistically significant reduction in the number of facial inflammatory lesions at all time points (weeks 4, 8 and 12).

Safety and Tolerability
BPX-04 appeared to be generally well-tolerated. The most commonly reported adverse events across both treatment groups were upper respiratory tract infection (5.3 percent), gastroenteritis (2.4 percent) and headache (2.4 percent) with the majority of these adverse events determined to be not treatment-related. There were no serious treatment-related adverse events.