HALETHORPE, Md., May 7, 2024 /PRNewswire/ — Fzata, Inc. is pleased to announce successful completion of a current good manufacturing practices (cGMP) run of lead drug, FZ002, with sufficient drug quantities to support the phase 1 first-in-human (FIH) clinical study.
FZ002 is a first-in-class live biotherapeutic yeast being developed for the prevention of recurrent Clostridioides difficile (C. diff) infection (CDI) with potential to expand to treating ongoing CDI and preventing primary CDI. FZ002 makes a proprietary tetra-specific antibody that neutralizes both C. diff toxins A and B. The upcoming FZ002 milestones include IND submission in 3Q2024 and FIH Phase 1 in 4Q2024. The trial will determine dosing regimen and safety as well as collecting information on yeast presence and drug activity.
“We are thrilled to bring breakthrough FZ002 to FIH trials. FZ002 is built on our proprietary multi-specific antibody platform and BioPYM™ platform and it will open a new frontier of patient-friendly, orally administered biologics. We have demonstrated safety and efficacy in multiple animal models of CDI. In fact, we have rescued highly susceptible animals and shown survival where all drugs have previously failed,” said Dr. Zhiyong Yang, Chief Executive Officer of Fzata. “With our strong NIH support and partnership of National Institute of Allergy and Infectious Diseases, we are ready to file the IND this summer and enter clinical studies late in the year.”
About C. diff.: This bacterium causes life-threatening diarrhea and colitis mostly in patients taking antibiotics. It is the most common healthcare-associated infection with about 500,000 suffering infections annually in the US and mortality approaching 13,000. Up to 35% of CDI will recur and of these, up to 60% will further recur with multiple recurrences observed.
About Fzata, Inc.: The Company has innovated and developed a next-generation oral biologics platform called Biotherapeutic Probiotic Yeast Medicines (BioPYM™). Leveraging BioPYM, the Company is developing proprietary, novel, oral biologic therapies to treat a wide variety of GI diseases and gut-health axis disorders. BioPYM transforms probiotic yeast into a micro-factory within the gut, producing therapeutics where the disease pathologies occur. The platform is designed to “plug and play” any gene to make any therapeutic protein, for example, monoclonal antibodies.
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For Investment opportunities, licensing, co-development, or collaboration inquiries, please contact:
Elizabeth Smith, PhD, MBA, Chief Business Officer, Fzata
E-mail: [email protected]
SOURCE Fzata, Inc.
