Fzata Announces Success in FZ002 Production and Phase 1 Trial

Fzata, Inc. has successfully completed a current good manufacturing practices (cGMP) production run of their lead drug, FZ002. This milestone ensures ample quantities of FZ002 are available to support the upcoming phase 1 first-in-human (FIH) clinical study. The achievement marks significant progress in the development of this innovative treatment.

FZ002 is a pioneering live biotherapeutic yeast aimed at preventing recurrent Clostridioides difficile (C. diff) infections, a common and dangerous condition often arising after antibiotic use. This novel treatment has the potential to also treat ongoing C. diff infections and prevent initial occurrences. FZ002 works by producing a unique tetra-specific antibody that neutralizes both C. diff toxins A and B.

The next steps in the FZ002 development include submitting an Investigational New Drug (IND) application in the third quarter of 2024, followed by initiating the phase 1 clinical trial in the fourth quarter of 2024. This trial will assess the dosing regimen and safety of FZ002, as well as gather data on the presence of the yeast and the activity of the drug within the body.

Dr. Zhiyong Yang, Chief Executive Officer of Fzata, expressed enthusiasm about the upcoming trials. He highlighted that FZ002 is built on Fzata's proprietary multi-specific antibody platform and BioPYM™ platform, which facilitates the creation of patient-friendly, orally administered biologics. Extensive preclinical testing has demonstrated FZ002’s safety and efficacy, including successful results in animal models where traditional treatments have failed.

Fzata's development efforts have been bolstered by strong support and partnerships, particularly with the National Institute of Allergy and Infectious Diseases (NIAID). According to Dr. Yang, this collaboration has positioned Fzata to file the IND promptly and proceed with clinical studies by the end of the year.

Clostridioides difficile is a bacterium that causes severe diarrhea and colitis, primarily affecting patients undergoing antibiotic treatment. It stands as the most prevalent healthcare-associated infection in the United States, with approximately 500,000 cases annually and nearly 13,000 deaths. The recurrence rate for C. diff infections is alarmingly high, with up to 35% of initial cases recurring, and of those, up to 60% experience multiple recurrences.

Fzata, Inc. is spearheading innovation with their BioPYM™ platform, which is at the heart of their development of next-generation oral biologics. BioPYM transforms probiotic yeast into micro-factories that produce therapeutic proteins directly in the gut, targeting the site of disease. This platform’s flexibility allows for the integration of any gene to produce various therapeutic proteins, including monoclonal antibodies.

In conclusion, Fzata's successful cGMP production of FZ002 and the forthcoming clinical trials represent significant advancements in the treatment of C. diff infections. The company's innovative approach and robust support from national health institutes underscore its potential to revolutionize oral biologic therapies for gastrointestinal diseases.