YSOPIA Successfully Completes Phase 1 Clinical Study of Xla1 Biotherapy for the Treatment of Obesity and Metabolic Diseases and Demonstrates its Excellent Safety Profile

• 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 a heatlhy human gut microbiome: Christensenella,

• The CAUSALITY study achieved its primary endpoint. Xla1 has shown an excellent safety and tolerability profile.

• Following these positive results, YSOPIA Bioscience plans to effectively conduct a subsequent Phase 2 clinical trial that should launch in the second half of 2022.

Bordeaux, France, July 6^th, 2021 – YSOPIA Bioscience, a French clinical stage biotechnology company specializing in the research and development of innovative biotherapies using the properties of keystone bacterial strains of the gut microbiome, today announced the completion of its CAUSALITY Phase 1 clinical trial, as well as the excellent safety and tolerability profile of Xla1, its flagship innovative biotherapy.

The CAUSALITY study evaluated the safety and tolerability of Xla1, the first oral biotherapy based on a unique living 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 the keystone role played by christensenella, a group of bacteria naturally present in the human gut microbiome that are missing in obesity and associated metabolic disorders.

Conducted in the United States of America, CAUSALITY enrolled a total of 38 volunteers, including healthy and obese subjects with metabolic abnormalities. The randomized, placebo-controlled double-blind protocol consisted in the daily oral administration of the Xla1 drug candidate in the form of gastro-resistant capsules for a 3-month period. No serious adverse events were reported, confirming the excellent safety and tolerability profile of Xla1 drug candidate.

Following this success, YSOPIA Bioscience intends to launch a Phase 2 clinical trial to evaluate the efficacy of its innovative biotherapy in obesity and associated metabolic abnormalities and to establish a first proof of concept of Christensenella in Humans. Initiation of this Phase 2 study is currently planned for the second half of 2022.

“We are extremely enthusiastic to achieve this significant milestone in the development of our innovative biotherapy. Our team is really proud of having brought Xla1 from preclinical to clinical stage in record time,”said Dr. Georges Rawadi, CEO of YSOPIA Bioscience. “This success allows us to go forward to Phase 2 to generate Proof of Concept in Humans. Futhermore, it will also accelerate the development of Christensenella in other applications of our pipeline. Thanks to this exciting step, we are getting closer to our final goal: bringing our groundbreaking biotherapy to patients with obesity. Obesity is a real pandemic worldwide and existing treatments have failed so far to delay its progression. We strongly believe that microbiome-based biotherapies represent a new hope for these patients.”

To learn more about Xla1 biotherapy, read YSOPIA’s publication:
Potential Biotherapy for Obesity and Associated Metabolic Diseases, Mazier et al., Cells, 2021
(https://www.mdpi.com/2073-4409/10/4/823)

About obesity:
Obesity is the most common worldwide health issue with over 650 million people being reported as suffering from obesity. 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.