LPOXY Therapeutics Enhances C. difficile Treatment with Acquisition of Xeno Assets

LPOXY Therapeutics Takes Bold Steps Toward C. difficile Prevention

In a strategic move aimed at tackling serious infections, LPOXY Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in infectious disease therapies, has announced the acquisition of select assets from Xeno Biosciences Inc. This acquisition not only consolidates LPOXY's ability to combat Clostridioides difficile (C. difficile) infection but also helps accelerate its pivotal developments in this essential area of healthcare.

Details of the Acquisition

On January 3, 2025, LPOXY disclosed that it had signed a term sheet for the acquisition. The assets acquired include regulatory filings, correspondences, and documentation from both the FDA and other global regulatory bodies. This wealth of information will be essential in advancing LPOXY’s medical efforts.

The company will benefit from clinical data that was generated from Xeno’s Phase I and Ib trials, confirming the safety of the Active Pharmaceutical Ingredient used in both firms' treatments. Additionally, with the inclusion of Xeno's intellectual property portfolio, LPOXY is further solidifying its proprietary stance in the market. In return for these assets, Xeno will become a shareholder in LPOXY and may receive up to $7.5 million in milestone payments. Significant to this transition is Dennis Kim, MD, CEO of Xeno Biosciences, who is set to join LPOXY's Board of Directors.

A New Therapeutic Mission: SIDIPREV™

The main aim of this acquisition is to bolster SIDIPREV™, a novel therapeutic candidate specifically designed to prevent C. difficile infections in hospitalized patients undergoing antibiotic treatment. LPOXY plans to kick off a pivotal Phase II study under the FDA's Limited Population Pathway for Antibacterial and Antifungal Development (LPAD). This pathway was established by Congress through the 21st Century Cures Act of 2016 to fast-track the development of crucial therapies for life-threatening infections.

The urgency of developing effective treatments for C. difficile is underscored by CDC reports indicating that this infection contributes to over 80 deaths daily in the United States. With a growing public health threat, the need for rapid intervention has never been more critical.

Seeking FDA's Fast Track for SIDIPREV™

In addition to initiating the clinical study, LPOXY is set to pursue a Qualified Infectious Disease Product (QIDP) designation for SIDIPREV™, which would provide an accelerated FDA review process and an extended five-year market exclusivity, projecting U.S. market protection until 2045. This designation, introduced by the GAIN (Generating Antibiotic Incentives Now) Act in 2012, aims to promote the development of antibiotics designed to combat resistant infections.

Larry Sutton, MD, PhD, founder and CEO of LPOXY Therapeutics, expressed enthusiasm about steering Xeno's innovations into a promising new therapeutic direction. He emphasized the importance of securing additional funding to support their clinical pursuits. Similarly, Dennis Kim, MD, highlighted the significance of continuing the legacy of promoting oxygen delivery to the gastrointestinal tract, noting that prevention of C. difficile infection is an essential public health priority.

Looking Ahead

LPOXY's acquisition of Xeno's assets marks a significant momentum shift in the ongoing battle against C. difficile infections, showcasing a commitment to addressing immediate health threats faced by vulnerable populations. As clinical trials progress and regulatory pathways are navigated, the advancement of SIDIPREV™ could represent a major breakthrough for those at risk of this dangerous infection.

For further details about LPOXY Therapeutics and its initiatives, interested parties can reach out to Larry Sutton at the provided contact information, or visit their website for real-time updates.

This acquisition strategy exemplifies how biotech firms are evolving in response to the pressing demands of public health threats and demonstrates the power of collaboration in the pursuit of medicine's next breakthrough.