BiomX Reports Topline Results of Phase 2 Cosmetic Acne Study
October 18 2021 - 7:00AM
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.
About BX001
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.
About BiomX
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.
Safe Harbor
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.
BiomX, Inc.Assaf OronChief Business Officer+972 (54)
222-8901assafo@biomx.com
Source: BiomX Inc
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