LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company, is developing a new way to prevent Clostridioides difficile infections (C. diff) that doesn’t rely on antibiotics. The company has signed a term sheet with 5 Horizons Ventures, a venture capital firm focused on healthcare innovation. This agreement backs a $28 million Series A funding round, which will allow LPOXY to build a broader investor group to support its upcoming registrational clinical trial called STOP-Cdiff. Officially named the SIDIPREV Trial On Prevention of C. difficile Infections, the trial will follow FDA guidance for drugs intended for limited populations.
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SIDIPREV is being designed as a preventive therapy for patients at high risk of developing severe C. diff infections, especially hospitalized individuals receiving antibiotics. The Centers for Disease Control and Prevention (CDC) considers C. diff a major public health threat, with the infection contributing to approximately 80 deaths per day in the United States. Unlike traditional antibiotics, SIDIPREV aims to restore gut balance. It is formulated as an enteric-coated oral capsule that delivers a metered dose of oxygen to the lower gastrointestinal tract. This oxygen-rich environment suppresses anaerobic bacteria like C. diff, reduces toxin production, and helps minimize inflammation.
The STOP-Cdiff trial will be a randomized, placebo-controlled study that will enroll approximately 500 hospitalized patients who are at increased risk due to age or recent antibiotic use. The primary goals are to demonstrate the safety and effectiveness of SIDIPREV. LPOXY plans to begin the trial in the third quarter of 2026 and targets FDA approval by 2029. Because SIDIPREV does not contribute to antibiotic resistance and addresses a large unmet need, the company believes it holds a strong position in the evolving healthcare landscape.
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Dr. Larry Sutton, CEO and co-founder of LPOXY, said the investment from 5 Horizons Ventures marks a major milestone for the company. He explained that SIDIPREV not only addresses a critical medical challenge but also aligns with hospital financial models by helping reduce complications that fall under fixed reimbursement categories. Sutton emphasized that this mix of clinical and economic benefits will be vital for broad adoption in hospital systems.
Paul Ferguson, Partner and CFO at 5 Horizons Ventures, commented that LPOXY’s leadership team has presented a strong vision supported by encouraging data. He noted that SIDIPREV avoids many of the common challenges that affect traditional antibiotic development, such as reimbursement issues and resistance. Instead, it represents a rare opportunity to generate meaningful impact for patients, healthcare providers, and investors. LPOXY is also in active discussions with other institutional investors who share its goal of moving SIDIPREV into late-stage trials and eventually into hospital use.
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