Syntis Bio Aims to Transform Oral Therapy for Obesity, Diabetes, and Rare Diseases

Syntis Bio, Inc. has recently emerged as a clinical-stage biopharmaceutical company dedicated to creating oral therapies that aim to provide more accessible, effective, and sustainable healthcare solutions. The company's primary focus is on harnessing the unique biology of the small intestine, a crucial organ for metabolic control, digestion, and drug absorption. Syntis Bio is advancing a portfolio of programs targeting a range of metabolic diseases, from obesity to rare pediatric conditions such as homocystinuria (HCU) and maple syrup urine disease (MSUD).

The company was co-founded by industry veteran Rahul Dhanda alongside esteemed Massachusetts Institute of Technology (MIT) scholars Robert Langer and Giovanni Traverso. Syntis Bio's leading program, SYNT-101, is currently undergoing human trials. Additionally, the company is progressing several rare disease treatments towards Investigational New Drug (IND)-enabling studies. In 2023, Syntis Bio secured $15.5 million in seed funding from prominent investors, including Safar Partners, BOLD Capital Partners, Touchdown Ventures, Colorcon Ventures, and Portal Innovations.

Commenting on the global obesity epidemic projected to affect 1.5 billion people by 2030, CEO Rahul Dhanda highlighted the limitations of current GLP-1 drugs in terms of accessibility, cost, side effects, and long-term maintenance. He expressed optimism about the promising results of SYNT-101 in human trials, noting that this once-daily pill could offer a convenient and accessible alternative or complementary therapy for obesity. By leveraging the small intestine’s therapeutic potential, Syntis Bio aims to address a wide array of health issues, from prevalent conditions like obesity and diabetes to rare diseases such as HCU and MSUD.

The SYNT-101 program works by mimicking the effects of gastric bypass surgery through a process known as duodenal nutrient exclusion. This mechanism blocks nutrient absorption in the upper part of the small intestine, redirecting nutrients to the lower small intestine, which stimulates the release of satiety hormones like GLP-1 and PYY. The current human trials aim to evaluate the pill's safety, tolerability, and efficacy in blocking nutrient absorption, with full results expected by the end of 2024. These findings will support Syntis Bio’s IND application with the U.S. Food & Drug Administration (FDA) in 2025.

The SYNT-101 pill is based on SYNT™ (SYNthetic Tissue-lining) technology, a polymer chemistry innovation developed by Drs. Langer and Traverso. This technology provides a temporary polydopamine coating to catalase-rich tissues in the gastrointestinal tract, which remains in place for up to 24 hours before being naturally cleared from the body. This versatile technology can achieve various therapeutic effects, including nutrient exclusion, gut-restricted enzyme installation, and enhanced drug bioavailability.

In April 2024, Syntis Bio expanded its pipeline by acquiring engineered enzyme therapies from Codexis, Inc. The company is now focusing on developing oral treatments for homocystinuria (SYNT-202) and maple syrup urine disease (SYNT-203). Both conditions lack approved disease-modifying therapies. Following successful non-human primate studies, Syntis Bio plans to submit an IND application for one of these treatments in 2025.

Syntis Bio is also working on next-generation formulations of SYNT-202 and SYNT-203, utilizing SYNT technology to enhance local therapeutic activity and duration. Additionally, the company is conducting discovery-stage research on solutions for pancreatic insufficiency and peptic ulcers.

The Syntis board of directors includes co-founders Dhanda, Langer, and Traverso, along with experienced strategists and company builders Teymour Boutros-Ghali and Martin Madaus. The company's mission is to develop oral therapies that optimize the small intestine's biology, offering treatments for both rare genetic disorders and common health conditions.