Fzata, Inc. has announced a major breakthrough in the fight against chronic visceral pain associated with inflammatory bowel syndrome (IBS). The company has been awarded a five-year, $7 million grant from the NIH’s National Institute of Neurological Disorders and Stroke (NINDS) to develop FZ006, a groundbreaking oral treatment for IBS-related pain. This significant funding will support pre-clinical and Phase 1 clinical trials for FZ006, a drug candidate based on Fzata’s innovative BioPYMTM platform technology.
The grant, a testament to Fzata’s promising research, will fund crucial steps in the development of FZ006, including IND-enabling studies, GLP toxicology, cGMP manufacturing, Phase 1 trial design, IND submission, and Phase 1a clinical trial. The research will be conducted in collaboration with the University of Maryland, Baltimore (UMB), further strengthening the project’s potential.
Dr. Zhiyong Yang, President and CEO of Fzata, highlighted the urgent need for effective IBS pain treatments. “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,” he stated. “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.”
Dr. Yang expressed enthusiasm for the collaborative effort, emphasizing the expertise of UMB and NINDS labs in bringing this game-changing treatment to patients. “We are excited to work with the outstanding team we assembled to bring a real game-changer to IBS patients and their families,” he added.
Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures, Baltimore, also expressed his excitement for the project. “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,” he said.
Robilotto also emphasized the continued progress of Fzata’s pipeline, citing FZ002, a drug candidate for C. difficile infections based on technology licensed from UMB. FZ002 is expected to enter first-in-human clinical trials in 2025.
Fzata’s BioPYMTM platform is a revolutionary approach to developing oral live biotherapeutics. It utilizes probiotic yeast as a micro-factory within the gut, producing therapeutics directly at the site of disease pathology. This “plug and play” platform can accept any gene to create biotherapeutic proteins, including monoclonal antibodies, enzymes, cytokines, and hormones. Fzata is leveraging this technology to develop a pipeline of proprietary drug candidates for a wide range of gastrointestinal diseases and gut-health axis disorders.
The NIH grant and Fzata’s innovative approach represent a significant step towards providing much-needed relief for millions suffering from IBS-related pain. With its potential for a safe and effective treatment, FZ006 offers hope for a future where chronic visceral pain is no longer a debilitating condition.
