The first in-human study of a once-daily oral treatment for obesity (SYNT-101) demonstrating positive preliminary data for the safe and effective redirection of nutrient absorption into the lower intestine was unveiled yesterday.
In the study, presented at this year’s European Congress on Obesity, participants were surveyed for adverse events, tolerability markers, as well as modulation of satiety hormones that influence hunger and weight loss.
The results suggest a strong safety and tolerability profile, along with control of hunger and weight loss.
“These data validate the potential of SYNT-101 to induce metabolic changes that support glycaemic control, weight loss and energy balance,” said Rahul Dhanda, chief executive officer of Syntis Bio, the Boston-based biopharmaceutical company developing SYNT-101.
“We believe that SYNT-101 will provide a convenient, more sustainable oral alternative and/or complement to systemic therapies such as GLP-1 drugs.
“The millions of people living with obesity need novel treatment options that are safe, effective and avoid the high costs and severe side effects that often accompany available treatment options.”
SYNT-101 mimics the effects of gastric bypass by forming a temporary polydopamine coating in the duodenum, shifting nutrient exposure to the lower intestine to naturally promote satiety and support metabolic balance.
In addition, this “duodenal nutrient exclusion” effect improves satiety and metabolic regulation, and has been shown to better preserve lean muscle mass compared to GLP-1 drugs.
The polydopamine lining is designed work for up to 24 hours, after which it is naturally cleared from the body.
SYNT-101 will ultimately be delivered in a once-daily oral pill.
In preclinical studies, SYNT-101 has shown promising effects on glycaemic control and produced weight loss of 1pc a week for six weeks while preserving 100pc of lean muscle mass in rodent models.
The authors note that larger trials are needed to fully assess the drug’s efficacy and safety.
Syntis Bio plans to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) during the second half of this year. “We are eager to replicate these data in our upcoming Phase 1 clinical trial and further explore the ability of SYNT-101,” Mr Dhanda said.
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