Proceeds will fund the registrational STOP-Cdiff (SIDIPREV™ Trial On Prevention of C. difficile Infections) trial for SIDIPREV™, positioned to become the first prevention against C. difficile, a deadly infection that claims 80 U.S. lives daily and lacks any approved preventive therapy.
PLATTE CITY, Mo., Sept. 3, 2025 /PRNewswire/ -- LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a novel non-antibiotic therapy to prevent Clostridioides difficile infections (Cdiff), today announced it has signed a term sheet with 5Horizons Ventures, LLC, a life science venture capital firm focused on innovative healthcare solutions in support of a $28 million Series A financing. The agreement facilitates the formation of an investment syndicate to fund LPOXY's registrational STOP-Cdiff (SIDIPREV™ Trial On Prevention of C. difficile Infections) clinical trial.
The upcoming trial is designed under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs guidance and is intended to serve as the registrational study for SIDIPREV™, a therapy that aims to prevent life-threatening Cdiff in high-risk hospitalized patients. C. difficile is categorized by the CDC as an urgent public health threat that kills 80 Americans every day.
"5 Horizons Ventures' commitment marks a major milestone for LPOXY as we move toward launching our pivotal STOP-Cdiff trial," said Dr. Larry Sutton, CEO and co-Founder of LPOXY. "SIDIPREV™ represents a novel approach to infection prevention that not only addresses a deadly unmet need but also aligns with hospital economics by reducing costly complications within fixed DRG payments."
SIDIPREV™ is an orally administered, enteric-coated capsule that releases a metered dose of oxygen into the lower gastrointestinal tract, creating an environment hostile to anaerobic pathogens like C. difficile. Oxygen also suppresses toxin production and has mucosal anti-inflammatory effects.
As planned, STOP-Cdiff is a randomized, placebo-controlled superiority trial that will evaluate the efficacy and safety of SIDIPREV™ in approximately 500 hospitalized patients at elevated risk for Cdiff due to age and antibiotic exposure. LPOXY aims to launch the trial in Q3 2026 and file for approval in 2029.
"We're impressed by the LPOXY team, their data, and their clear-eyed strategy for succeeding where many anti-infective programs have struggled," said Paul Ferguson, Partner and CFO of 5 Horizons Ventures. "SIDIPREV™ avoids the reimbursement and resistance-related hurdles that have plagued traditional antibiotics, making thisa rare opportunity to unlock real economic value for patients, hospitals, and investors."
LPOXY is actively building its investment syndicate and is in discussions with other institutional investors aligned with its late-stage clinical strategy.
For more information about LPOXY Therapeutics and its STOP-Cdiff trial, please contact:
Larry Sutton, MD, PhD
CEO, LPOXY Therapeutics Inc.
Phone: +1 (816) 200-0513
Email: larry@lpoxy.com
Visit our website at www.lpoxy.com for additional details and updates.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding the planned pivotal study of SIDIPREV™, regulatory filing and approval, and commercialization of LPOXY Therapeutics Inc.'s products. Forward-looking statements are based on LPOXY's current expectations and are subject to inherent risks and uncertainties that could cause actual results to differ materially from those anticipated in such statements. Risks and uncertainties include, among other things, the timing and success of clinical trials, the regulatory approval process, LPOXY's ability to secure necessary funding, the potential market acceptance of SIDIPREV™, and other factors detailed in LPOXY's filings with regulatory authorities.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, LPOXY undertakes no obligation to update any forward-looking statements to reflect new information, future events, or changes in circumstances.
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SOURCE LPOXY Therapeutics, Inc
