Fzata, Inc. Announces Multi-Million Dollar NIH Grant

Published in PR Newswire | September 24, 2024

Fzata, Inc. is pleased to announce a five-year UG3/UH3 non-dilutive grant (UG3NS135350) of up to $7 million, plus in-kind contributions, awarded by the NIH National Institute of Neurological Disorders and Stroke (NINDS). Grant participants include Fzata and the University of Maryland, Baltimore (UMB). The grant supports development of BioPYM™ drug candidate FZ006 as a safe and effective oral treatment for chronic visceral pain associated with inflammatory bowel syndrome (IBS). Work under the grant will include IND-enabling studies, GLP toxicology, cGMP manufacturing, phase 1 trial design, IND submission, and Phase 1a clinical trial.

Dr. Zhiyong Yang, President and CEO of Fzata, commented, “Chronic visceral pain associated with IBS is a serious unmet need. Ten to 15 percent of Americans suffer with severe pain, but treatment options are often inadequate. The most effective opioid treatments come with a high risk of addiction, a national problem. FZ006 will be the first effective, safe, non-addictive option to treat chronic abdominal pain. We are excited to work with the outstanding team we assembled, including labs at UMB and NINDS, to bring a real game-changer to IBS patients and their families.”

“This NIH award presents a wonderful opportunity for Fzata, one of UMB’s startup portfolio companies, to advance development of their platform technology for an important medical need. It’s gratifying that the funded work will be in collaboration with UMB scientists,” said Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures, Baltimore. “We are excited by Fzata’s continued pipeline advancements, including (“FZ002”) for C. difficile infections, which is based on technology licensed from UMB and expected to start first-in-human clinical trials in 2025.”

About Fzata, Inc.

The Company has innovated and developed a next-generation therapeutics platform called Bioengineered Probiotic Yeast Medicines (BioPYM™) for oral live biotherapeutics. BioPYM enables probiotic yeast to function as a micro-factory within the gut, producing therapeutics on site where disease pathologies occur. The “plug and play” platform accepts any gene to make biotherapeutic proteins including monoclonal antibodies, enzymes, cytokines, and hormones. Leveraging BioPYM, the Company has a pipeline of proprietary drug candidates to treat a wide variety of gastrointestinal diseases and gut-health axis disorders.