LPOXY Marks C. diff Awareness Month with First-in-Class Oral Preventive Preparing for Pivotal Trial

LPOXY is advancing SIDIPREV™ to a pivotal clinical trial to prevent C. difficile infections, which kill more Americans each year than all other CDC Urgent Threat infections combined.

PLATTE CITY, Mo., Nov. 3, 2025 /PRNewswire/ -- In recognition of C. diff Awareness Month, LPOXY Therapeutics, Inc. is drawing attention to the ongoing burden of Clostridioides difficile infection, a leading cause of serious healthcare-associated infections that costs the U.S. healthcare system billions of dollars each year and claims tens of thousands of lives. LPOXY's lead oral preventive, SIDIPREV™, targets the intestinal environment where C. difficile thrives, offering a new and scalable approach to infection prevention.

Founded in 2020 at the height of the pandemic, LPOXY advanced SIDIPREV™ from concept to pivotal-trial readiness during one of the most capital-starved periods the biotech industry has ever faced. While hundreds of early-stage biotechs stalled or folded, angel-backed LPOXY maintained steady momentum through disciplined execution, strategic asset integration and a lean operating model.

"We built this company in one of the toughest investment climates our industry has seen," said Larry Sutton, M.D., Ph.D., CEO of LPOXY Therapeutics. "That resilience defines who we are. As capital investments return to late-clinical innovation, we're exactly where investors and partners are looking. We're ready to deliver a pivotal trial in an urgent public-health indication."

The company's upcoming STOP-Cdiff clinical trial will evaluate SIDIPREV™ in hospitalized elderly adults receiving broad-spectrum antibiotics, the highest-risk group for C. difficile infection. With an FDA LPAD-aligned design and prior human safety data, the study positions SIDIPREV™ for potential NDA submission upon positive results.

"LPOXY represents the kind of post-pandemic innovation the industry needs," said Aaron Ray of 5 Horizons Ventures, an early participant in LPOXY's ongoing $28 million Series A syndicate. "They've built a durable organization through the hardest years in biotech and are now emerging into the recovery phase with a pivotal-ready asset."

The addressable U.S. market for primary C. difficile prevention exceeds $2 billion annually, driven by more than 11 million hospitalizations each year involving high-risk antibiotic use. Because SIDIPREV™ is designed for oral co-administration with antibiotics in existing inpatient workflows, its adoption aligns with hospital reimbursement incentives to prevent these costly superinfections, offering the economic profile of vaccine-like prevention with the scalability and margins of a pharmaceutical therapy.

The CDC classifies Clostridioides difficile as an urgent public health threat, and current prevention options are limited to infection control measures. C. difficile causes ten-fold more infections and excess healthcare costs than all other CDC Urgent Threat Pathogens combined.

For more information, please contact:
Larry Sutton, MD, PhD
CEO, LPOXY Therapeutics Inc.
Phone: +1 (816) 200-0513
Email: [email protected]
www.lpoxy.com

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.

SOURCE LPOXY Therapeutics, Inc