LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on innovative therapies for infectious disease prevention, announced that it has signed a term sheet to acquire selected assets from Xeno Biosciences Inc. 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.”