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Our Science

Shifting the therapeutic focus to the root causes of T2D and obesity

FRACTYL HEALTH ASSETS ARE POTENTIALLY POSITONED TO TARGET PREVIOUSLY UNADDRESSABLE CATEGORIES IN T2D AND OBESITY

1. FDA Draft Guidance: Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention February 2008 (withdrawn), Section V.B.5 Prevention of Type 2 Diabetes Mellitus 2. Buse et al Diabetes Care. 2009 32:2133-2135. 3. FDA Guidance for Industry Developing Products for Weight Management February 2007. 4. Adapted from Hatoum et al JAMA Surgery Feb 2016.

FRACTYL HEALTH DEVELOPMENT PIPELINE AIMS TO TRANSFORM THE ENTIRE METABOLIC SPECTRUM

1. Revita has been granted Breakthrough Device designation for the hydrothermal ablation of the duodenal mucosa to improve glycemic control and eliminate insulin needs in T2D patients inadequately controlled on long-acting insulin; and CE mark obtained from EU and UK in 2016 for Revita for the improvement of glycemic control in patients with inadequately controlled T2D despite oral and/or injectable glucose lowering medications and/or long-acting insulin.
2. The Germany Real World Registry study is a post-market, clinical follow-up study in real-world patients with inadequately controlled T2D on at least one ADA.
3. The Revitalize-1 study is a pivotal study in patients with inadequately controlled T2D despite being on up to three ADAs and daily insulin.
4. Product candidates under out Rejuva gene therapy platform will undergo Phase 1, Phase 2 and Phase 3 clinical trials. IND = Investigational New Drug Application with FDA or comparable regulatory body; IDE = Investigational Device Exemption.

Our Publications and Presentations

2022

Meiring, et al.  Eliminating exogenous insulin therapy in patients with type 2 diabetes by duodenal ablation and GLP-1 RA decreases risk scores for cardiovascular events. Cardiovascular Diabetology, 21:191, 2022.

van Baar, et al. Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study) Diabetes Research and Clinical Practice, 13 January 2022.

Meiring, et al. DMR with a GLP-1 receptor agonist increases postprandial unconjugated bile acids in patients with insulin-dependent T2D. American Journal of Physiology, Endocrinology and Metabolism, E132–E140, 31 January 2022.

Meiring, et al. A Changed Gut Microbiota Diversity Is Associated With Metabolic Improvements After Duodenal Mucosal Resurfacing With Glucagon-Like-Peptide-1 Receptor Agonist in Type 2 Diabetes in a Pilot Study, Frontiers in Clinical Diabetes and Healthcare, 05 July 2022.

2021

Rajagopalan, et al. “A Gut-Centric Model of Metabolic Homeostasis.” Journal of Diabetes Science and Technology, 0:1-08, October 2021.

Mingrone, et al. “Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial.” Gut, 0:1-11, January 2021.

2020

van Baar, et al. “Duodenal mucosal resurfacing combined with GLP-1RA to discontinue insulin in type 2 diabetes: a feasibility study.” Gastrointestinal Endoscopy, 0:1-10, December  2020.

van Baar, et al. “Duodenal mucosal resurfacing: Multicenter experience implementing a minimally invasive endoscopic procedure for treatment of type 2 diabetes mellitus.” Endoscopy International Open; 08: E1683–E1689, October 2020.

van Baar, et al. “Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study.” Gut, 69:295-303, January 2020.

2019

van Baar, et al. “Endoscopic duodenal mucosal resurfacing improves glycaemic and hepatic indices in type 2 diabetes: 6-month multicentre results.” JHEP Reports, Volume 1, Issue 6, 429-437, November 2019.

Haidry, et al. “Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting.” Gastrointestinal Endoscopy, Volume 90, Issue 4, 673-681.e2, October 2019.

2017

Cherrington, et al. “Hydrothermal Duodenal Mucosal Resurfacing Role in the Treatment of Metabolic Disease.” Gastrointestinal Endoscopy Clinics of North America, 27(2): 299-311, April 2017.

2016

Rajagopalan, et al. “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study.” Diabetes Care, 39, 1-8, August 2016.

Galvao, et al. “Hydrothermal duodenal mucosal resurfacing: a novel procedural therapy for metabolic disease.” VideoGIE, 1(1), 10-11, September 2016.

2023

Liou, et.al. World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC), Universal City, CA, Dec 2023

Rajagopalan, et al. European Association for the Study of Diabetes (EASD) 2023, Hamburg, Germany, October 2023

Rajagopalan, et al. American Diabetes Association 2023, San Diego, CA, June 2023

Fonseca, et al. American Diabetes Association 2023, San Diego, CA, June 2023

Galvani, et al. Digestive Disease Week (DDW) 2023, Chicago, IL USA, May 2023

Rajagopalan, et al. American Society of Gene and Cell Therapy, Los Angeles, CA, May 2023

Rajagopalan, et al. American Society of Gene and Cell Therapy, Los Angeles, CA, May 2023

2022

Liou, et al. World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC), Universal City, CA, Dec 2022

Busch, et al. United European Gastroenterology Week (UEGW), Vienna, Austria, Oct 2022

Meiring, et al. Digestive Disease Week (DDW) 2022, San Diego, CA, USA, May 2022

2021

Meiring, et al. Digestive Disease Week (DDW) 2021, Virtual, May 2021

2020

Meirling, et al. United European Gastroenterology Week 2020. Virtual, October 2020.

Chouhan, et al. ISMRM & SMRT Virtual Conference & Exhibition. Virtual, August 2020.

Hopkins, et al. Endocrine Online 2020 (ENDO). Virtual, June 2020.

Mingrone, et al. 80th American Diabetes Association Scientific Sessions (ADA). Virtual, June 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

Chouhan, et al. European Society of Gastrointestinal and Abdominal Radiology 2020 Virtual Congress (ESGAR). Amsterdam, The Netherlands, May 2020.

2019

Lopez-Talavera, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

van Baar, et al. Diabetes Technology Meeting (DTM). North Bethesda, MD, November 2019.

West, et al. ObesityWeek 2019. Las Vegas, NV, November 2019.

Bergman, et al. American Association for the Study of Liver Diseases (AASLD). Boston, MA, November 2019.

van Baar, et al. United European Gastroenterology Week 2019 (UEGW). Barcelona, Spain, October 2019.

Meiring, et al. 79th American Diabetes Association Scientific Sessions (ADA). San Francisco, California, USA, June 2019.

Hopkins. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

Hopkins, et al. 4th World Congress on Interventional Therapies for Type 2 Diabetes (WCITD). New York City, NY, USA, April 2019.

2018

Haidry, et al. Digestive Disease Week – Monumental Developments in Science & Medicine (DDW). Washington, DC, USA, June 2018.

Ghosh, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

van Baar, et al. 78th American Diabetes Association Scientific Sessions (ADA). Orlando, Florida, USA, June 2018.

deGravelle, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

Maggs, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2018.

Maggs, et al. American Association for the Study of Liver Diseases (AASLD). San Francisco, Calif., USA, November 2018.

2017

van Baar, et al. Digestive Disease Week (DDW). Chicago, Illinois, USA, May 2017.

Rajagopalan. 3rd Paris Nash Meeting. Paris, France, July 2017.

van Baar, et al. 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD). Lisbon, Portugal, September 2017.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA, October 2017.

Sacks, et al. American Heart Association Meeting (AHA). Anaheim, Calif., USA, November 2017.

2016

Rajagopalan, et al. 9th Diabetes Drug Discovery & Development Conference-GTC Diabetes Summit. Boston, Massachusetts, USA, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Galvao Neto, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

Rajagopalan, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

van Baar, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016

Cherrington, et al. 76th American Diabetes Association (ADA). New Orleans, Louisiana, USA, June 2016. [Oral]

Maggs. The Obesity Society (TOS). New Orleans, LA, USA, October 2016

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2016

Rajagopalan, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

2015

Cherrington, et al. Third World Congress on Interventional Therapies for Type 2 Diabetes (WCITT2D). London, UK, September 2015.

Cherrington, et al. United European Gastroenterology Week (UEGW). Barcelona, Spain, October 2015.

Cherrington, et al. 13th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRS). Los Angeles, Calif., USA, December 2015.

2014

Rajagopalan. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Holleman. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Rubino. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Galvao, et al. World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Montreal, Canada, August 2014.

Erase T2D

Advancing research on the role of the gut in metabolic disease

Led by world-renowned experts in metabolic disease, the EraseT2D task force shares Fractyl Health’s mission to build evidence, understand, and ultimately eradicate metabolic disease.

The Erase T2D task force builds on decades of discovery that have clearly identify the critical role of the gut as a regulator of metabolic disease. The signaling mechanisms between the gut and the rest of the body are numerous and not yet fully understood. The task force is charged with advancing research on the role of the gut in metabolic disease to catalyze future discoveries that may inform how diabetes can be better understood and ultimately erased.
This initiative, funded by Fractyl Health, is meant to spur the kind of innovative thinking and fundamental breakthroughs that will point the way toward a world without type 2 diabetes.

Erase Task Force

The ERASE T2D Task Force is comprised of the following members:

Alan Cherrington,
Ph.D.
(co-chair)

Professor of Molecular Physiology & Biophysics, Professor of Medicine, and Jacquelyn A. Turner and Dr. Dorothy J Turner Chair in Diabetes Research at Vanderbilt University School of Medicine

Harith Rajagopalan,
M.D., Ph.D.
(co-chair)

Co-founder and CEO of Fractyl Health

Dave D’Alessio,
M.D.

Professor of Medicine and Chief of Division of Endocrinology and Metabolism at Duke University School of Medicine

Geltrude Mingrone,
M.D., Ph.D.

Professor of Diabetes and Nutrition at King’s College, London; Associate Professor of Internal Medicine at Catholic University of Rome

Randy Seeley,
Ph.D.

Professor of Surgery and Director of Michigan Nutrition Obesity Research Center at Michigan School of Medicine