Syntis Bio, a clinical-stage biopharmaceutical company pioneering oral therapies that target the small intestine, has dosed the first patient in its Phase 1/1b SYNTIETY-1 trial of SYNT-101, the company’s lead investigational programme for obesity.
SYNT-101 is a once-daily oral pill engineered to redirect nutrient absorption beyond the small intestine’s duodenum, mimicking the effects of gastric bypass surgery without the need for invasive procedures.
“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. We are also thrilled to welcome Rosenbaum and Shalish to our leadership team as we accelerate clinical development and advance our broader pipeline.”
The Phase 1/1b trial, taking place in Australia, will evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of SYNT-101 in healthy volunteers and overweight or obese patients. A 28-day multi-ascending dose arm will also monitor changes in metabolic markers linked to weight management.
Alongside this milestone, Syntis Bio announced two key leadership hires: David Rosenbaum as Chief Development Officer, and Christo Shalish as Chief Business Officer.
“I am thrilled to join Syntis at this inflection point,” said Rosenbaum. “Launching the SYNT-101 clinical program is a significant milestone that reflects our continued progress in advancing a differentiated obesity pipeline into the clinic. I look forward to helping guide clinical development for both SYNT-101 and future programs that will combine the SYNT platform with additional therapies.”
“SYNT-101 and the SYNT platform represent a differentiated solution to oral therapeutics,” commented Shalish. “As the program advances clinically, we are focused on forging strategic partnerships and building durable, long-term value for SYNT-101 and beyond.”