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

LEXINGTON, Mass.–(BUSINESS WIRE)–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 first
U.S. 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 dollar
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.

Contacts

Corporate Contact:
Lisa Davidson
Chief Financial Officer
Fractyl
Laboratories Inc.
lisa@fractyl.com
+1.781.902.8800

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

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