Boston– Syntis Bio, a clinical-stage biotech company focused on transforming treatment options for obesity and metabolic disorders, presented encouraging new data on its lead candidate, SYNT-101, at the European Congress on Obesity and Weight Management.
The investigational drug, designed as a once-daily oral alternative to more invasive or injectable treatments, showed both safety and early signs of effectiveness in preclinical and first-in-human studies. SYNT-101 works by mimicking the effects of gastric bypass surgery — a gold standard in obesity treatment — through a novel mechanism that redirects nutrient absorption within the gut.
In a small pilot study involving nine participants, researchers evaluated the safety and tolerability of SYNT-101 at three different dose levels. No treatment-related side effects were reported, and tissue biopsies revealed normal histology across the board. Moreover, the study showed clear signs of nutrient redirection and positive changes in appetite-regulating hormones. Participants experienced increased leptin (a hormone that promotes satiety) and decreased ghrelin (a hunger stimulant), suggesting enhanced satiety and better metabolic regulation.
In parallel preclinical studies involving diet-induced obese rodents, daily administration of SYNT-101 led to an average 6.1% body weight reduction over six weeks — approximately 1% per week — along with a 10% decrease in calorie intake and an 8% drop in fasting glucose levels. Notably, the animals retained 100% of their lean muscle mass during the trial, addressing a key limitation of many current obesity treatments, including GLP-1-based drugs.
“These results reinforce our belief that SYNT-101 can become a convenient and effective oral treatment for obesity,” said Rahul Dhanda, CEO of Syntis Bio. “Unlike GLP-1 therapies, which often carry risks like muscle loss and gastrointestinal side effects, SYNT-101 appears to offer weight loss without those trade-offs — and may even work synergistically with GLP-1s.”
Obesity expert and Syntis advisor Dr. Louis Aronne echoed Dhanda’s enthusiasm, calling SYNT-101’s safety profile and muscle-sparing effects “an important advance in obesity care.”
Syntis Bio plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the second half of 2025, paving the way for formal Phase 1 clinical trials.
If further studies confirm the early findings, SYNT-101 could represent a game-changing new approach in a crowded yet still underserved obesity treatment market — offering patients a once-daily pill that targets weight loss through the gut, without needles or major surgery.