LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company, has acquired key assets from Xeno Biosciences Inc. to advance SIDIPREV™, a novel therapy aimed at preventing Clostridioides difficile infections in hospitalized patients receiving antibiotic treatment. The acquisition, announced on January 3, 2025, includes regulatory filings, correspondence with the FDA, comprehensive CMC data, and intellectual property.
Strategic Acquisition to Combat Urgent Health Threat
The assets acquired from Xeno Biosciences include data from Phase I and Ib clinical trials, which validate the safety of the active pharmaceutical ingredient shared by Xeno's and LPOXY's drug products. In exchange for these assets, Xeno will become a shareholder in LPOXY Therapeutics and may receive milestone payments totaling up to $7.5 million. Dennis Kim, MD, CEO of Xeno Biosciences, will also join LPOXY's Board of Directors.
SIDIPREV™: A Novel Approach to C. difficile Prevention
SIDIPREV™ is designed to be co-administered with antibiotics, the primary risk factor for C. difficile infections. The therapy works by increasing the oxygen concentration in the gut, which is toxic to the anaerobic pathogen C. difficile, preventing it from establishing an infection. According to Larry Sutton, MD, PhD, founder and CEO of LPOXY Therapeutics, this approach aims to "prevent [C. difficile] from ever happening in the first place."
Regulatory Strategy and Clinical Development
LPOXY plans to initiate a pivotal Phase II study under the Food and Drug Administration's (FDA) Limited Population Pathway for Antibacterial and Antifungal Development (LPAD). The LPAD pathway, established under the 21st Century Cures Act of 2016, is designed to expedite the development of therapies for serious, life-threatening infections in limited populations with unmet medical needs. LPOXY also intends to seek Qualified Infectious Disease Product (QIDP) designation for SIDIPREV™, which would grant FDA fast-track review and an additional five years of regulatory exclusivity, potentially extending U.S. market protection through 2045. The QIDP designation was established by the GAIN (Generating Antibiotic Incentives Now) Act, included in the FDA Safety and Innovation Act (FDASIA) of 2012.
Addressing an Urgent Public Health Need
C. difficile has been identified by the Centers for Disease Control and Prevention (CDC) as an urgent public health threat, contributing to more than 80 American deaths each day. The initial clinical trials for SIDIPREV™ will focus on elderly patients hospitalized with pneumonia, a population at high risk for contracting a secondary C. difficile infection, especially when combined with antibiotic use. "The most urgent need is in hospitalized elderly patients, and that’s what we’re targeting first," Sutton stated. "There’s no other therapy to prevent these infections in this group."
Future Directions
While the initial focus is on hospitalized elderly patients, LPOXY recognizes the broader risk of C. difficile infections associated with antibiotics prescribed in the community. The company plans to further develop SIDIPREV™ for broader indications through traditional Phase III trials after securing initial approval through the LPAD pathway.
