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YSOPIA Bioscience Announces the First Positive Safety Results of its CAUSALITY Study in Obesity and Associated Metabolic Disorders, as well as the Inclusion of the Obese Patients in the Second Arm of the Trial

Mar 4, 2021
  • CAUSALITY is the world’s first clinical study evaluating the therapeutic potential of Xla1, an innovative biotherapy based on the properties of a unique bacterial strain naturally present in the human gut microbiome: Christensenella.

  • The data from the first arm of healthy volunteers support the good safety profile of Xla1.

  • Obese patients presenting metabolic disorders have been included in the second arm.

  • The full results of the CAUSALITY study are expected during the third quarter of 2021.

 

Bordeaux, France, March 04th, 2021 – 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 that it has obtained the first positive safety data from the arm of healthy volunteers and has completed enrollment and begun to treat obese patients in its CAUSALITY Phase I clinical trial.

The primary objective of the CAUSALITY study is to evaluate the safety and tolerability of Xla1, the first oral biotherapy based on a unique bacterial strain of Christensenella, in the treatment of obesity and associated metabolic abnormalities.

Since their discovery in 2012, numerous international scientific publications, supported by YSOPIA’s own research, have highlighted that the keystone role played by christensenella, a group of bacteria naturally present in the human gut microbiome, notably in preventing obesity and a number of metabolic disorders.

The protocol of the CAUSALITY study consists of the daily oral administration of the Xla1 drug candidate in the form of gastro-resistant capsules.

No adverse effects have been detected to date, which supports the Xla1 drug candidate’s good safety profile.

On the basis of the positive safety results obtained in the first arm of the CAUSALITY study comprising 8 healthy volunteers, YSOPIA has begun to treat the second arm of the study, which will consist of 30 obese patients suffering from metabolic disorders. The full results of the CAUSALITY study are expected during the third quarter of this year.

These first highly promising safety data support the pertinence of our approach of directly applying, to human health, the therapeutic properties of bacteria naturally present in the human gut microbiome”, said Dr. Georges Rawadi, CEO of YSOPIA Bioscience. Until now, the development of treatments targeting obesity has frequently come up against problems associated with the safety, tolerance or side effects induced by the products. There is therefore an urgent need for new therapeutic paradigm in this indication. The good safety profile of our innovative biotherapy opens up the unique therapeutic potential of this treatment and may lead to the development of a highly innovative and effective solution for millions of obese people around the world”.

About obesity:

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 indicate 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, people with obesity may suffer from social as well as psychological impairments.

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