Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes

LEXINGTON, Mass., March 18, 2019 — Fractyl Laboratories Inc. (Fractyl) today announced the hiring of Margaret Borys as Chief Commercial Officer (CCO) and Juan Carlos Lopez-Talavera, M.D., Ph.D. as Chief Medical Officer (CMO). These additions come as Fractyl is preparing for commercialization efforts outside the U.S. and has started the company’s U.S. pilot clinical trial for its lead product candidate Revita™ DMR for the treatment of type 2 diabetes and fatty liver disease.


Revita DMR (duodenal mucosal resurfacing) is a minimally-invasive, outpatient procedural therapy designed to reverse insulin-resistant metabolic diseases, including type 2 diabetes and nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), by addressing their root cause in the intestine. The U.S. pilot follows successful clinical trials in the European Union and South America, involving more than 200 patients. These studies, which include randomized, multicenter trials, showed a single treatment with Revita DMR was well tolerated and appears capable of producing sustained reductions in blood glucose levels, insulin use, insulin resistance, liver fat and inflammation, and weight.


“As Revita DMR advances through U.S. clinical trials for regulatory approval, Margaret’s highly relevant industry expertise and knowledge of the metabolic disease market will become increasingly valuable, particularly for the development of commercial strategies in the United States and in the European Union, where Revita DMR already has a CE Mark,” said Harith Rajagopalan, M.D., Ph.D., cofounder and CEO of Fractyl. “Likewise, Juan Carlos’ addition to the team provides guidance and experience to advance the company’s clinical pipeline as we develop novel, disease-modifying therapies for metabolic diseases, including type 2 diabetes and NAFLD/NASH.”


“I was impressed with Fractyl’s breakthrough data from its clinical studies, as well as the company’s scientific insights and innovative approach in treating the gut to target the root cause of metabolic disease,” said Borys. “I am excited to join Fractyl at this inflection point where the company has significant, supportive clinical data and is poised to initiate commercialization outside the United States and, with regulatory approval, a product launch in the United States.”


Borys brings more than 26 years of industry experience to her new role, having held positions in corporate strategy, commercial operations, global brand management, business technology, finance, and business consulting. She has direct experience with Fractyl’s core market of metabolic diseases; most recently leading Sanofi’s multibillion U.S. diabetes biologics business. Prior to Sanofi, Borys worked for Pfizer, Wyeth, and Arthur Andersen.


Dr. Lopez-Talavera has more than 20 years of experience in drug development for liver and gastrointestinal diseases.


“The number of patients with type 2 diabetes and NAFLD/NASH is increasing at an alarming rate, and new approaches to addressing the epidemic are sorely needed,” said Dr. Lopez-Talavera. “I see that Fractyl’s Revita system, rooted in a new and important scientific insight of the critical role of the gut in causing metabolic disease, offers a paradigm-shifting approach to address this major public health challenge affecting millions of patients around the world.”


Prior to joining Fractyl, Dr. Lopez-Talavera was Chief Medical Officer at Enterome Biosciences. Previous to that, he held positions at Intercept as Senior Vice President, Head of Medical Affairs; AbbVie as Head of Medical Affairs, Global Research and Development; Bristol Myers Squibb as Vice President and Global Development Lead; and Roche Laboratories as Senior Medical Director. Before these industry roles, Dr. Lopez-Talavera was assistant professor with the Divisions of Gastroenterology and Hepatology, and Endocrinology and Pathology at the University of Pittsburgh Medical Center. He has been an author on more than 120 research publications and abstracts in hepatology and liver diseases.


About Fractyl and Revita™ DMR


Fractyl Laboratories is a private medical technology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH. The Revita DMR procedure harnesses breakthrough insights in the role of the duodenum in causing insulin resistance and metabolic diseases to develop novel interventions designed to restore metabolic health. The Revita DMR System received a CE mark in the European Union in April 2016. It has been approved for investigational use by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs.

Corporate Contact: Lisa Davidson, Chief Financial Officer, Fractyl Laboratories Inc., lisa@fractyl.com,+1.781.902.8804

Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com,+1.858.344.8091