C. difficile Clinical Trial Agreement for Fzata's FZ002

HALETHORPE, Md., March 11, 2025 /PRNewswire/ -- Fzata, Inc. announces the execution of a clinical trial agreement with the National Institutes of Health (NIH) to sponsor a Phase 1 clinical trial of FZ002 for C. difficile treatment. Oral FZ002 is a live yeast genetically modified to express a tetraspecific anti-toxin for C. difficile in the gastrointestinal (GI) tract. FZ002 is a first-in-class multi-benefit C. difficile treatment, offering ­­­­potent and broad-spectrum neutralization of both toxins A & B, targeted GI delivery, and probiotic activity without promoting the generation of antibiotic-resistant superbugs.

"In addition to advancing drug candidate safety and dosing, positive trial results will bolster confidence in the BioPYM platform as a groundbreaking therapeutics modality.  No needle oral biologics with no cold-chain will transform the patient experience with biologic therapies," said Dr. Zhiyong Yang, Chief Executive Officer of Fzata. "We are grateful that NIH provided critical support for our new oral-biologics modality, demonstrating their deep commitment to the BioPYM FZ002 program and the clinical need for a safer and more effective C. difficile treatment."

Dr. Wilbur Chen MD, an adult infectious disease expert at The University of Maryland School of Medicine, Center for Vaccine Development and Global Health commented, "I am excited to be the Protocol Chair of this clinical trial which will evaluate a novel therapeutic candidate to determine whether it works to avoid the known risks of broad-spectrum antibiotics, which have been the standard approach to the treatment and prevention of recurrent C. difficile infections (CDI). Instead, FZ002 holds the potential of treating CDI without further perturbing the intestinal microbial population."

About C. difficile: The bacterium can cause life-threatening diarrhea in patients taking antibiotics. There are about 500,000 CDIs annually in the US, up to 35% of patients will recur, and, of these, up to 60% will further recur with multiple recurrences observed.

About Fzata, Inc.: The Company has developed a next-generation oral biologics modality called Bioengineered Probiotic Yeast Medicines (BioPYM™). BioPYM utilizes live yeast to carry a DNA payload and functions as a "micro-factory" to produce therapeutic biologics directly in the GI. Fzata has a deep pipeline of yeast drug candidates for GI diseases and gut-health axis disorders. 

For additional Fzata information, visit www.fzata.com or follow us on LinkedIn.com/company/Fzata

For Investment opportunities, licensing, co-development, or collaboration inquiries, please contact:

Elizabeth Smith, PhD MBA, Chief Business Officer, Fzata
E-mail: [email protected]

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SOURCE Fzata, Inc.