LPOXY Therapeutics, Inc. Acquires Key Assets from Xeno Biosciences Inc. to Advance C. difficile Prevention Therapy

PLATTE CITY, Mo., Jan. 3, 2025 /PRNewswire/ -- LPOXY Therapeutics, Inc. ("LPOXY"), a clinical-stage biopharmaceutical company focused on innovative therapies for infectious disease prevention, announced today that it has signed a term sheet to acquire selected assets from Xeno Biosciences Inc. ("Xeno"). The assets include regulatory filings, correspondence, and documentation from FDA and global regulatory interactions, as well as comprehensive CMC data. LPOXY will benefit from ownership of data generated in Xeno's Phase I and Ib clinical trials, which validates the safety of the Active Pharmaceutical Ingredient shared by Xeno's and LPOXY's drug products. Additionally, LPOXY will acquire Xeno's intellectual property portfolio, further strengthening its proprietary position. In exchange, 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 join LPOXY's Board of Directors.

LPOXY will use these assets to advance SIDIPREV™, a novel therapy aimed at preventing Clostridioides difficile infections in hospitalized patients receiving antibiotic treatment. The company 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 by Congress 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. 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.

LPOXY also plans 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, extending U.S. market protection through 2045. QIDP designation was established by the GAIN (Generating Antibiotic Incentives Now) Act, included in the FDA Safety and Innovation Act (FDASIA) of 2012, to stimulate the development of treatments for drug-resistant infections.

"We are excited to advance Xeno's technology in a new therapeutic direction and to begin a pivotal Phase II study as we secure funding to support our clinical goals," said Larry Sutton, MD, PhD, founder and CEO of LPOXY Therapeutics.

Dennis Kim, MD, mentioned that: "We are enthusiastic to have LPOXY continue our legacy of delivering oxygen to the gastrointestinal tract. While Xeno wasn't able to prove that this was beneficial for weight loss, prevention of C. difficile infection is an important public health issue, and we fully support LPOXY's mission to advance this groundbreaking approach to protect vulnerable patients and save lives."

For more information about LPOXY Therapeutics and its development programs, please contact:

Larry Sutton, MD, PhD
CEO, LPOXY Therapeutics Inc.
Phone: +1 (816) 200-0513
Email: [email protected]
Visit our website at www.lpoxy.com for additional details and updates.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the anticipated development, regulatory approval, and commercialization of LPOXY Therapeutics Inc.'s products, the planned pivotal Phase II study of SIDIPREV™, potential applications for QIDP designation, and the anticipated regulatory exclusivity period. 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