Xeno Biosciences Initiates Phase 1b Obesity Study

Xeno Biosciences Inc., a clinical-stage drug discovery and development company based in Cambridge, Massachusetts, has announced the commencement of a Phase 1b clinical trial. The study is centered on evaluating the proof-of-concept for weight loss, alongside safety and tolerability, using an optimized formulation of their drug candidate XEN-101 in obese adults. The initial results from this trial are anticipated by the end of the year.

The Phase 1b trial is structured as a double-blind, randomized, placebo-controlled, parallel-group study. It will test multiple doses of XEN-101 against a placebo over a four-week period involving 32 adult participants with a Body Mass Index (BMI) between 30 and 45 kg/m2. The primary goals of the study include assessing safety, tolerability, and the total body weight change at the end of the four-week period. Additionally, the trial will examine pharmacodynamic effects such as microbiome composition, serum ketone levels, metabolic biomarkers, and changes in self-reported appetite and hunger.

Dr. Dennis Kim, President and CEO of Xeno Biosciences, expressed confidence in the study's design, anticipating that it will demonstrate proof-of-concept for body weight reduction after four weeks of therapy. Dr. Kim highlighted the oral administration schedule and the novel mechanism of action as key features that position XEN-101 as a promising candidate to address unmet needs in the obesity treatment landscape.

Xeno Biosciences Inc. is privately held and focuses on developing treatments for obesity and metabolic diseases. The company’s lead candidate, XEN-101, aims to provide an effective and well-tolerated oral treatment for obesity. The development of XEN-101 is informed by insights into the mechanism of action of Roux-en-Y Gastric Bypass Surgery (RYGB), with the goal of mimicking the effects of this surgery in a daily oral pill. Initial clinical trials have shown XEN-101 to have a high safety margin and excellent tolerability.

In summary, Xeno Biosciences’ new Phase 1b trial aims to deliver crucial data on the effectiveness and safety of XEN-101 in promoting weight loss in obese adults. With results expected by the end of the year, this study represents a significant step forward in the development of a novel obesity treatment that could meet a substantial unmet medical need.