BiomX Reports Topline Results of Phase 2 Cosmetic Acne Study
12-Week Study of BX001 Meets Safety and Tolerability Endpoints
Statistically Significant Improvement from Baseline Observed in Appearance of Acne-prone Skin but No Meaningful Difference Demonstrated Relative to Vehicle
Subject Satisfaction Questionnaire Outcomes Indicate Preference for BX001 Over Vehicle on Key Parameters
BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 18, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: 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.
BX001 is a topical gel formulation of a cocktail of naturally-occurring phage designed to improve the appearance of acne-prone skin by targeting Cutibacterium acnes (C. acnes), which are bacteria implicated in the pathophysiology of acne vulgaris. BX001 has been shown in vitro to be active on antibiotic resistant C. acnes strains and that it does not target other, potentially beneficial, bacteria on the skin. Furthermore, BX001 has been shown in vitro to penetrate biofilms, a matrix secreted by the bacteria which surrounds them and makes them less accessible to substances such as antibiotics. Biofilms exist in the pilosebaceous unit, where undesirable C. acnes are found.
BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as target bacteria in the treatment of chronic diseases, such as inflammatory bowel disease, primary sclerosing cholangitis, cystic fibrosis, atopic dermatitis and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
Additional information is available at www.biomx.com, the content of which does not form a part of this press release.
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX discusses its expectations regarding further evaluation of the data from the BX001 study, determining and communicating potential next steps for the BX001 development program and the timing of reporting additional clinical milestones, and to the extent such results are positive, including data readouts in its cystic fibrosis, atopic dermatitis and inflammatory bowel disease programs, BiomX is making forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2021 and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
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Source: BiomX Inc
Released October 18, 2021