Xeno Biosciences Inc., a clinical stage drug discovery and development company advancing therapeutics for the treatment of obesity and metabolic diseases, announced today initiation of Phase 1b clinical study which is designed to provide proof-of-concept weight loss results, along with safety and tolerability, using an optimized formulation of the drug candidate XEN-101, in obese adults. The trial is expected to have top line results by the end of the year.

The Phase 1b study is a double blinded, randomized, placebo controlled, parallel group design testing multiple doses of Xen-101 vs. placebo over 4-week period in 32 adults with BMI between 30 and 45 kg/m2. The study is being conducted in Australia and safety, tolerability, and total body weight change at the 4-week endpoint will be the primary objectives. Pharmacodynamic effects, including microbiome composition, serum ketone levels, metabolic biomarkers, and changes in self-reported appetite and hunger will also be investigated.

“We’re confident that this study design will deliver proof-of concept body weight reduction results after 4-weeks of therapy in the background of already documented excellent safety and tolerability profile,” said Dr. Dennis Kim, President and CEO of Xeno Biosciences. “With a daily oral administration schedule and a novel and differentiated mechanism of action, we believe Xeno is well-positioned to demonstrate Xen-101 as a new, exciting, and sought-after drug candidate that can address the strong and remaining unmet needs in the obesity field.” The results of the Phase 1b study are expected by the end of 2024.

For more information about Xeno Biosciences please contact Dr. Dennis Kim at dk23@xenobiosciences.com.

About Xeno Biosciences Inc. Xeno Biosciences Inc. is a privately held drug development company dedicated to finding safe and effective treatments for obesity and metabolic diseases. Xeno is advancing its lead development candidate, XEN-101, to address the unmet need for an effective, well-tolerated, orally administered obesity treatment. With a new understanding of the underlying mechanism of action of Roux-en-Y Gastric Bypass Surgery (RYGB), Xeno has developed a substitute for gastric bypass in a daily oral pill. XEN-101 has been shown to have wide safety margins and high tolerability in initial clinical trials.

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For more information about Xeno Biosciences please contact Dr. Dennis Kim at dk23@xenobiosciences.com.