top of page

Xeno Biosciences initiate phase 1b proof-of-concept study for obesity drug candidate XEN-101

Xeno Biosciences has initiated a Phase 1b clinical study designed to provide proof-of-concept weight loss results, along with safety and tolerability, using an optimised formulation of the drug candidate XEN-101, in adults with obesity.

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,

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.

XEN-101 is a gut-restricted, non-systemic compound with excellent safety profile observed in preliminary animal tox studies. XEN-101 is designed to deliver molecular oxygen to the lower gut in a targeted fashion to modulate the gut microbiome and intestinal environment. Delivery of oxygen to the distal gut generates a new environment in the gut, driving a shift in microbiota manifested by increased aerotolerant bacteria abundance.

The altered gut microbiota and luminal environment drives a weight loss response, which is thought to be triggered by neuronal and immune signalling from the gut to the brain (gut-brain axis).

The Phase 1b study is a double blinded, randomised, placebo controlled, parallel group design testing multiple doses of Xen-101 vs. placebo over four-week period in 32 adults with BMI 30-45 kg/m2. The study is being conducted in Australia and safety, tolerability, and total body weight change at the four-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.


bottom of page