LPOXY Therapeutics, a clinical-stage biopharmaceutical company focused on preventing Clostridioides difficile infections without antibiotics, has taken a significant step forward in its development journey. The company has signed a term sheet with 5Horizons Ventures, a life sciences venture capital firm known for backing transformative healthcare technologies. This agreement sets the stage for a $28 million Series A financing round, which will support the launch of LPOXY’s registrational STOP-Cdiff clinical trial. The trial is designed to evaluate SIDIPREV, the company’s novel therapy aimed at preventing life-threatening C. difficile infections in vulnerable hospitalized patients.
C. difficile remains one of the most serious and persistent threats in healthcare settings. The Centers for Disease Control and Prevention classify it as an urgent public health concern, responsible for the deaths of approximately 80 Americans every day. The infection disproportionately affects older adults and those exposed to antibiotics, often leading to severe gastrointestinal illness, prolonged hospital stays, and increased mortality. Despite its prevalence, current treatment options are limited, and prevention strategies have struggled to keep pace with the growing burden.
LPOXY’s approach is fundamentally different. SIDIPREV is a non-antibiotic therapy delivered as an orally administered, enteric-coated capsule. Once in the lower gastrointestinal tract, it releases a carefully metered dose of oxygen. This oxygen-rich environment disrupts the conditions that allow anaerobic pathogens like C. difficile to thrive. In addition to its antimicrobial effects, oxygen also suppresses toxin production and reduces inflammation in the gut lining, offering a multi-pronged defense against infection.
The upcoming STOP-Cdiff trial will be a randomized, placebo-controlled superiority study involving approximately 500 hospitalized patients who are considered at high risk due to age and recent antibiotic use. The trial is being designed in alignment with the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, which provides a regulatory framework for therapies targeting serious infections in defined patient populations. If successful, STOP-Cdiff will serve as the registrational study for SIDIPREV, paving the way for a potential approval and commercial launch.
LPOXY plans to initiate the trial in the third quarter of 2026, with a regulatory filing targeted for 2029. In the meantime, the company is actively building its investment syndicate and engaging with additional institutional investors who share its vision for tackling antimicrobial resistance and improving outcomes for high-risk patients. The Series A financing will not only fund the clinical trial but also support continued development, manufacturing scale-up, and regulatory engagement.
The company’s progress reflects a broader shift in how the healthcare industry is approaching infectious disease prevention. With growing concerns about antibiotic overuse and resistance, there is an urgent need for therapies that work through alternative mechanisms. SIDIPREV represents a promising step in that direction, offering a targeted, non-antibiotic solution that could change the standard of care for C. difficile prevention.
KEY QUOTES:
“5 Horizons Ventures’ commitment marks a major milestone for LPOXY as we move toward launching our pivotal STOP-Cdiff trial. 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.”
Dr. Larry Sutton, CEO and co-Founder of LPOXY
“We’re impressed by the LPOXY team, their data, and their clear-eyed strategy for succeeding where many anti-infective programs have struggled. 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.”
Paul Ferguson, Partner and CFO of 5 Horizons Ventures
