BOSTON, Mass. — Syntis Bio has dosed the first patient in its Phase 1/1b SYNTIETY-1 clinical trial evaluating SYNT-101, an investigational once-daily oral therapy for obesity designed to mimic the metabolic effects of gastric bypass surgery.
The clinical-stage biopharmaceutical company said the study marks a key milestone for its SYNT platform, which targets the biology of the small intestine to develop oral treatments that can be used alone or alongside other therapies.
“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 Dr. Rosenbaum and Mr. Shalish to our leadership team as we accelerate clinical development and advance our broader pipeline.”
The Phase 1/1b trial is being conducted in Australia and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SYNT-101 in healthy volunteers and in overweight or obese patients. A 28-day multi-ascending dose arm will also assess changes in metabolic markers associated with weight management.
SYNT-101 works by transiently blocking nutrient absorption in the duodenum and redirecting nutrients to the distal small intestine. This approach aims to stimulate natural satiety and metabolism-regulating hormones, including GLP-1, through a mechanism known as duodenal nutrient exclusion — a key driver of the weight-loss effects seen with gastric bypass surgery.
Preclinical data showed preservation of lean muscle mass alongside consistent weekly weight loss in rodent models, and early human data indicated evidence of nutrient redirection and satiety hormone modulation. The company reported no adverse events in those early studies.
Alongside the clinical update, Syntis announced two executive appointments. David Rosenbaum, Ph.D., has joined as Chief Development Officer, and Christo Shalish has been named Chief Business Officer.
“I am thrilled to join Syntis at this inflection point,” said Dr. Rosenbaum. “The company’s mission and scientific approach have immense potential to help patients, globally and across the healthcare spectrum. 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.”
Dr. Rosenbaum brings more than 20 years of experience in clinical development and regulatory strategy across gastrointestinal, metabolic and cardiovascular diseases. He previously served as Chief Development Officer at Ardelyx, where he led development programs including Xphozah and Ibsrela through FDA approval. He has also held senior roles at several biotechnology companies, advancing small-molecule and non-systemic therapies from early-stage studies through registration.
Mr. Shalish joins Syntis with more than two decades of experience in business development and corporate strategy. He most recently served as Senior Vice President of Business Development and Strategy at Flagship Pioneering and has held leadership roles at Frontier Medicines, Novo Nordisk, Dicerna Pharmaceuticals, Moderna, Warp Drive Bio, Cubist Pharmaceuticals and ActivBiotics.
“SYNT-101 and the SYNT platform represent a differentiated solution to oral therapeutics,” said Mr. Shalish. “As the program advances clinically, we are focused on forging strategic partnerships and building durable, long-term value for SYNT-101 and beyond.”
The company said SYNT-101 may ultimately be used alongside GLP-1 agonists for potential additive or synergistic effects as it advances through clinical development.
