Fzata Secures Multi-million Dollar NIH Grant

Fzata, Inc., based in Halethorpe, Maryland, has been awarded a substantial grant from the NIH National Institute of Neurological Disorders and Stroke (NINDS). The five-year UG3/UH3 grant, identified as UG3NS135350, is valued at up to $7 million, supplemented by in-kind contributions. This funding supports the advancement of Fzata's BioPYM™ drug candidate, FZ006, intended as an oral treatment for chronic visceral pain linked to inflammatory bowel syndrome (IBS). The collaboration involves Fzata and the University of Maryland, Baltimore (UMB), focusing on several critical development phases, including IND-enabling studies, GLP toxicology, cGMP manufacturing, phase 1 trial design, IND submission, and Phase 1a clinical trial.

Fzata aims to offer a non-addictive solution to the chronic abdominal pain experienced by IBS patients with its FZ006 drug candidate. Dr. Zhiyong Yang, President and CEO of Fzata, highlighted the urgent need for such treatment, pointing out that 10 to 15 percent of Americans endure severe pain due to IBS. Current opioid treatments, though effective, carry a significant risk of addiction. Fzata's innovative approach promises a safe alternative, potentially transforming the lives of IBS patients and their families. The development effort brings together experts from Fzata, UMB, and NINDS, forming a robust team to drive this promising drug candidate forward.

Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures, Baltimore, expressed enthusiasm for the NIH grant. He emphasized the benefit of UMB's collaboration with Fzata, a company within UMB's startup portfolio. Robilotto also noted Fzata's progress in other areas, including the development of FZ002 for C. difficile infections. This project, based on technology licensed from UMB, is expected to enter first-in-human clinical trials by 2025.

Fzata has pioneered a platform known as Bioengineered Probiotic Yeast Medicines (BioPYM™) for oral live biotherapeutics. This next-generation therapeutics platform allows probiotic yeast to act as micro-factories within the gut, producing therapeutic agents directly at the disease site. The versatile "plug and play" system can incorporate various genes to generate biotherapeutic proteins such as monoclonal antibodies, enzymes, cytokines, and hormones. Fzata's pipeline leverages BioPYM to create proprietary drug candidates targeting a range of gastrointestinal diseases and disorders related to gut health.

The grant from NINDS represents a significant milestone for Fzata, enabling the company to advance its innovative treatments and address critical medical needs. With the collaborative efforts of UMB scientists and the support of NIH funding, Fzata is well-positioned to make meaningful advancements in the treatment of chronic visceral pain and other gastrointestinal conditions. The company's ongoing developments and partnerships underscore its commitment to transforming healthcare through innovative biotherapeutics.