Benzinga | Oct 18, 2021 07:08AM EDT

BiomX Reports Results Of Phase 2 Cosmetic Acne Study Showed Statistically Significant Improvement From Baseline Observed In Appearance Of Acne-prone Skin But No Meaningful Difference Demonstrated Relative To Vehicle

BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage cocktails that target specific pathogenic bacteria, today announced results from its Phase 2 cosmetic clinical study assessing the potential of BX001 to improve the appearance of skin in acne prone subjects. BX001 was demonstrated to be safe and well-tolerated, with no treatment-related adverse events. A statistically significant improvement from baseline was observed in the appearance of acne-prone skin but no meaningful difference was demonstrated relative to vehicle.

"Today we report topline results from our vehicle controlled, Phase 2 cosmetic acne study," said Jonathan Solomon, Chief Executive Officer of BiomX. "Compared to our prior Phase 1 trial, this study enrolled significantly more subjects and tested BX001 over a longer application period, so we were pleased to see that BX001 maintained an excellent safety and tolerability profile. However, we are disappointed that BX001 did not demonstrate a meaningful differentiation from vehicle on efficacy. We will further evaluate the data from this study before communicating potential next steps for the BX001 development program."

"BiomX continues to maintain a diversified pipeline targeting different pathogenic bacteria addressing areas of high unmet need. For the months ahead, we continue to look forward to reporting additional clinical milestones, including data readouts in our cystic fibrosis, atopic dermatitis, and inflammatory bowel disease programs."

The Phase 2 cosmetic clinical study in acne was a 12-week randomized, single center, double-blind, placebo-controlled trial in 140 women with mild-to-moderate acne vulgaris. Subjects were randomized into two cohorts: BX001 or placebo (vehicle) in a 1:1 ratio with BX001 or placebo self-administered twice daily. The key endpoints evaluated the safety, tolerability, and efficacy of BX001.

Significant improvements in the appearance of acne prone skin, as assessed by reduction in inflammatory lesion counts (48.3%, p<0.0001), non-inflammatory lesion counts (36.3%, p<0.0001), and reduction in mean Investigator's Global Assessment (IGA) score (-0.29, p<0.001), were observed when compared to baseline for both cohorts. No meaningful difference was demonstrated for BX001 relative to vehicle.

Subject satisfaction reported outcomes indicate preference for BX001 over vehicle in key parameters. Over 80% of subjects using BX001 reported reduction in skin redness and tenderness of skin bumps, indicated that the product left skin hydrated and noticeably improved the feel of their skin.