Full Press Release Details
BiomX Announces Positive Topline Results from
Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO)
The Company will host a conference
call and webcast today at 9:00 AM ET, followed by a Key Opinion Leader (KOL) event on April 3, 2025, at 11:00 AM ET to discuss the results
NESS ZIONA, Israel, March 31, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE
American: PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage
therapies that target specific pathogenic bacteria, today announced positive, topline safety and efficacy results from the Company's
DFO Adaptive Novel Care Evaluation (DANCE ) Phase 2 trial evaluating its BX211 phage treatment for DFO associated with Staphylococcus
aureus (S. aureus). The findings demonstrated BX211 to be safe and well-tolerated and that patients receiving BX211 exhibited
statistically significant1 and sustained reduction of ulcer size (PAR)(p = 0.046 at week 12; p=0.052 at week 13), with a separation
from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1
improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according
to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment
period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy
as appropriate. Following the successful Phase 2 readout of BX211, the Company is planning for a Phase 2/3 trial, pending discussions
and feedback from the U.S Food and Drug Administration.
"We believe these data represent one of the strongest demonstrations
to date of the therapeutic potential of phage therapy. We are grateful to all the patients who participated, and the treating teams who
enrolled patients into the study, as well as the continued and ongoing support from the U.S. Defense Health Agency (DHA) for this program,"
said Jonathan Solomon, BiomX's Chief Executive Officer. "Today, 30-40% of DFO cases lead to lower extremity amputations related
to serious bacterial infections, accounting for the majority of the 160,000 lower limb amputations in diabetic patients each year in the
United States. Based on the results announced today, we believe BiomX's novel phage therapy approach has the potential to help address
the major unmet need in DFO. Moreover, in an era of modern conflict and rising antibiotic-resistant wounds, the need for innovative wound
care solutions underscores the broader relevance of this program beyond DFO. BiomX is dedicated to the advancement of phage therapy, which
we believe holds promise in redefining the treatment of chronic infections."
"Phage therapy has a critical role to play in treating infections
where antibiotic resistance has emerged or existing treatments have underperformed," said Dr. Robert T. "Chip" Schooley,
M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative
Phage Applications and Therapeutics at the University of California, San Diego. "The promising topline data in this trial provide
an important inflection point for this approach and its potential to address the most challenging infections."
"Diabetic foot infections are often a complex and difficult-to-treat
consequence of diabetes, leading to serious adverse effects on patient quality of life," said Dr. Benjamin A. Lipsky, M.D., FACP,
FIDSA, FRCP (London), FRCPS (Glasgow), Professor of Medicine Emeritus at University of Washington, Seattle. "The most serious and
feared complication of DFO is lower extremity amputation, which is associated with a five-year mortality rate of about 50%. With the progress
seen so far and given the improved ulcer healing seen in this study, BX211 may have the potential to reduce amputations. BX211 is a program
to watch closely as it progresses into more advanced clinical studies."
Summary of Phase 2 BX211 Results
BiomX's Phase 2 trial is a randomized, double-blind, placebo-controlled,
multi-center study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S. aureus.
The study enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous (IV) and topical administration
of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm. Over the 12-week
treatment period, all subjects (treatment and placebo) were also treated in accordance with standard of care, including with systemic
antibiotic therapy as appropriate. A readout of study results at week 13 evaluated healing of the wound associated with osteomyelitis.
The primary efficacy endpoint was PAR of study ulcer through week 13. Study design was guided in part by experience with numerous compassionate
cases using phage therapy for the treatment of DFO and osteomyelitis.
The topline Phase 2 results included:
BiomX expects to present additional data from the Phase 2 study at
upcoming scientific conferences.
Today's Conference Call and Webcast Information
management will host a conference call and webcast today at 9:00 AM ET to review the topline Phase 2 trial results, accompanied by a
slide deck presentation, which will be available on the Company's website and filed via Form 8-K. To participate in the conference, please
dial +877-407-0724 (U.S.), or +1 201-389-0898 (International),
or click on the webcast link here.
A live and archived webcast of the call will also be available on the
Investors section of the Company's website at www.biomx.com.
BiomX to Host Virtual KOL Event - April 3, 2025
has scheduled a virtual KOL Event to discuss the topline results from the Phase 2 trial. The event will take place on April 3, 2025,
at 11:00 am ET, and will include participation from BiomX senior management and two KOLs, Dr. Robert T. "Chip" Schooley,
M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative
Phage Applications and Therapeutics at the University of California, San Diego, and Dr. Benjamin A. Lipsky, M.D., FIDSA, FRCP (London),
FRCPS (Glasgow) Professor of Medicine Emeritus at University of Washington, Seattle. To register for the event, please click here.
BX211 is a phage treatment for the treatment of
DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer
and is a leading cause of amputation in patients with diabetes. Pending feedback from the FDA, BiomX is planning for a Phase 2/3 clinical
BiomX is a clinical-stage company leading the development
of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment
of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ("BacteriOphage
Lead to Treatment") platform to customize phage compositions against these targets. For more information, please visit 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 refers to the potential safety and toleration of BX211, the potential benefits of BX211, future clinical
development of BX211 and the relevance and potential of phage therapy in the treatment of chronic infections, it is using 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's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the
possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in
pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development
activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials,
BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue
or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical
trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce
intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition;
uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's
ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025,
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.
Head Corporate Communications