BOSTON–(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 surgery via a transient, self-clearing synthetic intestinal lining. These 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
These results build on earlier preclinical and first-in-human pilot findings demonstrating SYNT-101’s adhesion, tolerability, and clearance within 24 hours. Preclinical models also indicate that SYNT-101 may result in consistent weight loss without a plateau, as well as preservation of muscle mass.
“These SAD results give us confidence in SYNT-101’s potential to deliver meaningful weight-loss benefit, which we expect to be further informed by the multiple ascending dose data later this year. The degree of nutrient redirection observed, together with favorable tolerability, further validates both SYNT-101’s mechanism and the broader potential of our SYNT platform,” said Rahul Dhanda, Chief Executive Officer of Syntis Bio. “We believe SYNT-101 offers a differentiated, complementary approach to GLP-1s, while our platform creates a unique opportunity to combine synergistic weight loss mechanisms – including existing and next generation GLP-1s and programs from our own obesity pipeline – in a single pill.”
The 28-day multiple ascending dose (MAD) arm of the SYNTIETY-1 trial will evaluate changes in relevant metabolic markers associated with weight management in overweight or obese patients. Enrollment in the cohort is now complete and Syntis Bio expects to announce data from this arm later this year.