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Syntis Bio Reports Positive Initial Phase 1/1b Single Ascending Dose Data for SYNT-101, Supporting its Novel Approach to Obesity Treatment
Business Wire
Thu 16 July 2026 at 4:30 pm GMT+5:30
5 min read
SYNT-101 was well tolerated across all doses with no related GI adverse events, no serious adverse events, and no discontinuations
Data confirm SYNT-101’s intended mechanism of nutrient redirection, with reduced glucose absorption and favorable changes in satiety hormones after a single dose
Additional data from the multiple ascending dose arm of the trial in obese patients is expected later this year
BOSTON, July 16, 2026–(BUSINESS WIRE)–Syntis Bio, Inc. a clinical-stage biopharmaceutical company advancing novel oral therapeutics that uniquely leverage the small intestine, today announced initial safety, tolerability, and pharmacodynamic data from the single ascending dose (SAD) arm of its ongoing Phase 1/1b SYNTIETY-1 clinical trial evaluating SYNT-101
SYNT-101, the Company’s lead investigational program for the treatment of obesity is an investigational once-daily oral tablet designed to replicate the metabolic effects of bariatric surgerye data will be presented at the 4th Obesity & Weight Loss Drug Development Summit being held July 14-16, 2026, in Boston
“Results from the SAD arm validate SYNT-101’s core mechanism of action, affirm its potential for best-in-class tolerability among weight management therapies, and demonstrate early indications of efficacy,” said David Rosenbaum, Ph.D., Chief Development Officer of Syntis Bio. “SYNT-101 is built on the premise that by altering where nutrients are sensed in the gastrointestinal tract, the hormonal response will be activated similarly to gastric bypass surgery, but without surgical intervention. Observing delayed nutrient absorption alongside notable increases in satiety hormones GLP-1 and PYY after a single tablet is direct evidence that SYNT-101 triggered that same distal-gut signaling pathway we set out to replicate.”
The randomized, double-blind, placebo-controlled SAD portion of SYNTIETY-1 was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of SYNT-101 in healthy volunteers. Thirty-two healthy adult volunteers were dosed across four ascending cohorts (857 mg to 3,428 mg, corresponding to one to four tablets). Data highlights include:
SYNT-101 was well tolerated at all dose levels, with no discontinuations, no serious adverse events, and no related GI adverse events
The only treatment-related adverse event observed was mild, self-limited hypoglycemia occurring during oral glucose tolerance testing (OGTT)
Continuous glucose monitoring during OGTT showed direct evidence of nutrient redirection with a 17% reduction in glucose absorption versus baseline over the measured duration
Single-tablet dosing was associated with favorable shifts in post-prandial endogenous satiety-related hormones, including: a 58% increase in total GLP-1, a 125% increase in peptide YY, a 21% reduction in ghrelin, and a 100% increase in leptin
