PLATTE CITY, Mo., Jan. 3, 2025 — LPOXY Therapeutics, Inc. (“LPOXY”), a clinical-stage biopharmaceutical company specializing in innovative infectious disease prevention therapies, announced a term sheet agreement to acquire key assets from Xeno Biosciences Inc. (“Xeno”). These assets encompass regulatory filings, communications, and documentation from FDA and global regulatory interactions, along with comprehensive CMC data. LPOXY will gain ownership of data from Xeno’s Phase I and Ib clinical trials, confirming the safety of the Active Pharmaceutical Ingredient common to both companies’ drug products. Furthermore, LPOXY will acquire Xeno’s intellectual property portfolio, enhancing its proprietary position. In return, Xeno will receive LPOXY shares and may receive milestone payments up to $7.5 million. Dennis Kim, MD, CEO of Xeno Biosciences, will join LPOXY’s Board of Directors.
pipeline to prevent the urgent threat of C. difficile.LPOXY will leverage these assets to advance SIDIPREV, a novel therapy designed to prevent Clostridioides difficile infections in hospitalized patients undergoing antibiotic treatment. The company intends to launch a pivotal Phase II study utilizing the Food and Drug Administration’s (FDA) Limited Population Pathway for Antibacterial and Antifungal Development (LPAD). The LPAD pathway, created by Congress through the 21st Century Cures Act of 2016, accelerates the development of therapies for serious, life-threatening infections affecting limited populations with unmet medical needs. The Centers for Disease Control and Prevention (CDC) has classified C. difficile as a critical public health threat, causing over 80 American deaths daily.
LPOXY also plans to pursue Qualified Infectious Disease Product (QIDP) designation for SIDIPREV, which would provide FDA fast-track review and an extra five years of market exclusivity, extending U.S. market protection until 2045. The QIDP designation, established by the GAIN (Generating Antibiotic Incentives Now) Act within the FDA Safety and Innovation Act (FDASIA) of 2012, aims to encourage the development of treatments for drug-resistant infections.
“We are pleased to advance Xeno’s technology into a new therapeutic area and initiate a pivotal Phase II study as we secure funding for our clinical objectives,” stated Larry Sutton, MD, PhD, founder and CEO of LPOXY Therapeutics.
Dennis Kim, MD, commented: “We are thrilled to see LPOXY continue our work on delivering oxygen to the gastrointestinal tract. While Xeno couldn’t demonstrate its weight-loss benefits, preventing C. difficile infection is a significant public health concern, and we fully support LPOXY’s mission to advance this innovative approach to safeguarding vulnerable patients and saving lives.”
For more information on LPOXY Therapeutics and its development programs, please contact:
Larry Sutton, MD, PhD
CEO, LPOXY Therapeutics Inc.
Phone: +1 (816) 200-0513
Email:
Visit our website at for additional details and updates.
Forward-Looking Statements
This press release includes forward-looking statements, covering anticipated development, regulatory approval, and commercialization of LPOXY Therapeutics Inc.’s products, the planned pivotal Phase II study of SIDIPREV, potential QIDP designation applications, and the projected regulatory exclusivity period. These statements reflect LPOXY’s current expectations and are subject to inherent risks and uncertainties that could significantly alter actual results. Risks and uncertainties include, but are not limited to, clinical trial timing and outcomes, the regulatory approval process, LPOXY’s ability to obtain necessary funding, potential market acceptance of SIDIPREV, and other factors detailed in LPOXY’s regulatory filings.
Readers are advised against over-reliance on these forward-looking statements, which are only current as of this press release’s date. Unless legally required, LPOXY does not commit to updating any forward-looking statements to reflect new information, future events, or changing circumstances.
SOURCE LPOXY Therapeutics, Inc
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