First patient dosed in trial of SYNT-101 for obesity

The first patient has been dosed in Syntis Bio's the Phase 1/1b SYNTIETY-1 clinical trial of SYNT-101, the company’s lead investigational program for the treatment of obesity. SYNT-101 is designed as a once-daily oral pill that redirects nutrient absorption past the small intestine’s duodenum, mimicking the effects of gastric bypass surgery.

SYNT-101 works by transiently blocking nutrient absorption in the duodenum, the upper part of the small intestine, and redirecting nutrients to the distal small intestine to stimulate the natural secretion of satiety and metabolism-regulating hormones, including GLP-1. This mechanism, known as duodenal nutrient exclusion, is a key contributor to the efficacy of gastric bypass surgery, which is considered a gold standard for quality weight loss and metabolic disease management.

Preclinical data demonstrated 100% preservation of lean muscle mass with consistent 1% weekly weight loss in rodent models, while first-in-human data showed that SYNT-101 demonstrated strong evidence of nutrient redirection and satiety hormone modulation. Importantly, SYNT-101 displayed strong safety and tolerability across both studies, with no adverse events reported. SYNT-101, which is being currently evaluated in the Phase 1/1b SYNTIETY-1 (SYNThetic Intestinal ExclusIon Therapy for ObesitY) study in obesity, may be used in conjunction with GLP-1 agonists for potential additive/synergistic effects. SYNT employs mussel-inspired polymer chemistry to deliver a safe, transient polydopamine coating to catalase-rich tissues such as the duodenum.

“Dosing of our first SYNTIETY-1 patient is a significant milestone for Syntis and for the SYNT-101 clinical program,” said Rahul Dhanda, Chief Executive Officer of Syntis Bio. “This progress underscores the potential of our SYNT platform, which is designed to harness the biology of the small intestine to develop the next generation of oral therapeutics, either as monotherapy treatments or as co-formulations to enhance or combine the effects of other drugs.”

The Phase 1/1b trial is being conducted in Australia and is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of SYNT-101 in healthy volunteers and in overweight or obese patients. The 28-day multi-ascending dose arm of the trial will also evaluate changes in relevant metabolic markers associated with weight management.