XEN-101

XEN-101 is an investigational treatment for obesity to be evaluated in a Phase I clinical trial. XEN-101 is a first-in-class oral formulation, engineered to produce weight loss by mimicking the microbiota changes induced by gastric bypass surgery.

To date, XEN-101 demonstrated profound weight loss effects in animal models and humans with limited side effects.

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 signaling from the gut to the brain (gut-brain axis).

OBESITY

Obesity is a chronic, relapsing, multifactorial, neurological disease, wherein an abnormal increase in body fat results in adverse metabolic, bio-mechanical, and psychosocial health consequences. Nearly 40 percent of U.S. adults have obesity, and more than 18 percent of children and teens also have obesity. This condition disproportionately affects people from certain racial and ethnic groups and those who are socio-economically disadvantaged.

Individuals with obesity may suffer devastating health problems, face reduced life expectancy, suffer from depression, experience stigma and discrimination. Obesity is a driver of type II diabetes, fatty liver disease, and many other disorders. Despite its major impact on health and quality of life, there are limited treatment options apart from bariatric surgery (gastric bypass).

Gastric bypass is a profoundly effective intervention, leading to 30% body weight loss sustained over decades. It halves all-cause mortality and resolves co-morbidities of obesity such as diabetes and fatty liver. Despite its substantial benefits, gastric bypass is a highly invasive, major abdominal surgery with likelihood of serious surgical complications.