Syntis Bio Announces First Patient Dosed in Phase 1/1b Clinical Trial of SYNT-101 in Obesity and Key Leadership Additions

David Rosenbaum, Ph.D., joins as Chief Development Officer

Christo Shalish joins as Chief Business Officer

BOSTON--(BUSINESS WIRE)--Syntis Bio, Inc. a clinical-stage biopharmaceutical company advancing novel oral therapeutics that uniquely leverage the small intestine, today announced that the first patient has been dosed in 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.

“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 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.

In conjunction with this clinical milestone, Syntis Bio also announced the appointments of David Rosenbaum, Ph.D., as Chief Development Officer, and Christo Shalish as Chief Business Officer, further strengthening the company’s leadership team as it enters a pivotal phase of growth.

“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.”

“SYNT-101 and the SYNT platform represent a differentiated solution to oral therapeutics,” commented 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.”

Dr. Rosenbaum brings more than two decades of experience in clinical development and regulatory strategy across gastrointestinal, metabolic and cardiovascular diseases. Prior to joining Syntis Bio, he served as Chief Development Officer at Ardelyx, where he led development efforts for multiple programs. Most notably, he guided Xphozah® and Ibsrela® through FDA approval for the treatment of hyperphosphatemia in chronic kidney disease and irritable bowel syndrome with constipation, respectively. Earlier in his career, Dr. Rosenbaum held senior development roles at Fenway Pharmaceuticals, Trine Pharmaceuticals, Phaedrus Pharmaceuticals and GelTex Pharmaceuticals, where he advanced small-molecule and non-systemic therapeutics from first-in-human studies through late-stage development and registration, building a track record of disciplined execution in high-unmet-need indications. As Chief Development Officer, Dr. Rosenbaum will oversee the company’s clinical and technical development capabilities and the advancement of the pipeline through development and regulatory milestones.

Mr. Shalish joins Syntis Bio with more than two decades of experience in business development, corporate strategy and strategic partnering across the biotechnology and pharmaceutical sectors. He has led numerous transformational transactions involving novel platforms and differentiated therapeutic assets. Prior to joining Syntis Bio, Mr. Shalish served as Senior Vice President of Business Development and Strategy at Flagship Pioneering. Previously, he held senior business development and alliance leadership roles at Frontier Medicines, Novo Nordisk, Dicerna Pharmaceuticals, Moderna, Warp Drive Bio, Cubist Pharmaceuticals and ActivBiotics. As Chief Business Officer, Mr. Shalish will oversee partnering, corporate development, and strategic initiatives, including collaborations spanning SYNT-101, the company’s obesity portfolio, and the broader SYNT platform.

About SYNT-101

SYNT-101 is being developed as a once-daily pill for the treatment of obesity. 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.

About SYNT™ Technology

Syntis Bio’s pipeline programs leverage the power of SYNT™ (SYNthetic Tissue-lining), an oral therapeutic technology designed to enhance disease-modifying activity within the small intestine, the body’s nexus for metabolic control, digestion, and drug absorption. SYNT™ employs mussel-inspired polymer chemistry to deliver a safe, transient polydopamine coating to catalase-rich tissues such as the duodenum. Following deployment in the gastrointestinal tract, the polydopamine lining is sustained for up to 24 hours and is then naturally and safely cleared from the body. In addition to nutrient exclusion, SYNT™ can be designed to install and sustain gut-restricted enzymes in the small bowel, enhance the oral bioavailability of drugs, and enable targeting of new tissues throughout the body.

About Syntis Bio

Syntis Bio is a clinical-stage biopharmaceutical company with a growing pipeline across obesity and rare disease. The company is currently enrolling a Phase 1/1b clinical study to evaluate lead program SYNT-101 in obesity. Syntis Bio’s pill-based synthetic tissue platform unlocks the therapeutic potential of the small intestine by creating a safe, tolerable and temporary lining that allows precise, programmable control of both nutrient and drug absorption. Syntis Bio is rapidly advancing a pipeline of oral therapies engineered for targeted activity in the small intestine, the body’s nexus for metabolic control, digestion and drug absorption. Alongside SYNT-101, the company is advancing a portfolio of therapies in obesity and in orphan metabolic diseases. Syntis Bio is headquartered in Boston, MA. For more information, please visit www.syntis.bio and follow us on LinkedIn.

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