Bordeaux, France, December 7th, 2020 – YSOPIA Bioscience, a French clinical stage biotechnology company specializing in the research and development of innovative drugs using the properties of key bacterial strains of the gut microbiome, today announced the recruitment and treatment of the first volunteers of its Phase 1 clinical trial, named CAUSALITY, which evaluates Xla1 in the treatment of obesity and metabolic disorders.
Xla1 – YSOPIA’s lead drug candidate – is an oral biotherapy using the properties of a unique living bacterial strain of Christensenella, a true keystone of the intestinal microbiome. Since their discovery in 2012, Christensenella showed, in several scientific publications in Europe, the United States and Asia, a strong potential in the prevention of obesity and associated metabolic diseases. Their absence in the gut microbiome is a major factor in the development of obesity and several metabolic disorders. Finally, it has been shown that the relative abundance of Christensenella bacteria in the human gut microbiome is inversely proportional to the Body Mass Index (BMI) of patients and to several markers related to metabolic diseases.
Strong proof-of-concept studies conducted by YSOPIA in preclinical models have also demonstrated a significant efficacy of Xla1 on obesity and associated metabolic markers.
The CAUSALITY study will primarily evaluate the safety and tolerability of Xla1 compared to placebo. Conducted in the U.S.A., CAUSALITY plans to recruit 38 volunteers, including healthy volunteers and obese volunteers with metabolic disorders. Xla1 will be delivered daily in the form of oral gastro-resistant capsules.
Obesity is the most important worldwide health issue with over 650 million people being reported to be obese. Overweight and obesity are recognized by the World Health Organization as the fifth highest risk of death in the world. Projections by the World Obesity Federation indicates that by 2025, more than one billion people worldwide will be obese. Owing to their condition, obese patients are at an elevated risk for developing other health related problems such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and many others. Moreover, obese people suffer from social as well as psychological impairments.