YSOPIA Bioscience

• 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 reported 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 consists 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”. 

• By finalizing the industrialization process for the manufacture of clinical batch of its Xla1 product candidate, LNC Therapeutics accomplished a key challenge in the production of anaerobic gut bacteria
• Xla1, an innovative single strain Live Biotherapeutic Product (LBP), is a first-in-class therapy targeting obesity and metabolic disorders

Bordeaux, 12th March 2020 – LNC Therapeutics, a French biotech company specializing in the research and development of innovative drugs harnessing the potential of the gut microbiome, announced today the successful completion of production of the first cGMP (current Good Manufacturing Practice)-compliant batch of its leading drug product candidate Xla1, an LBP based on a specific single-strain of Christensenella minuta. LNC Therapeutics is developing Xla1 as a novel therapy to treat obesity and metabolic disorders.

The completion of cGMP production marks a crucial milestone for the company’s planned first-in-man clinical trial of Xla1. LNC Therapeutics has developed an efficient, scalable and cGMP-compliant process to power the manufacturing of Xla1 as an oral gastro-resistant capsule, specifically formulated for easy daily intake. 

“Current anti-obesity treatments have shown unpleasant safety issues and limited efficacy,” commented Dr. Georges Rawadi, Chief Executive Officer of LNC Therapeutics. “We believe that the use of gut keystone bacteria, such as christensenella, has the potential to transform the management of obesity and its associated metabolic disorders. Developing and upscaling the production of christensenella is particularly challenging given it is an anaerobic bacteria that cannot tolerate the presence of oxygen, so the completion of Xla1-GMP manufacturing is a major step in our strategy towards developing this potential first-in-class therapy.”

LNC Therapeutics’ Xla1 obesity and metabolic disorders program is built on a strong scientific rationale and body of evidence demonstrating the role of christensenella as a cornerstone bacteria in human health. Xla1 was selected based on the company’s preclinical data demonstrating significant efficacy and a strong safety profile in relevant disease models.

More than 650 million people worldwide are obese. Obesity represents the fifth leading risk for global deaths, and the prevalence of obesity is expected to be 50% of the population in 5 to 10 years. Obese patients are at an increased risk for developing health problems, including type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and many others.

About Live Biotherapeutic Products (LBPs): According to the US Food and Drug Administration, a live biotherapeutic product contains live organisms, such as bacteria, and is applicable to the prevention, treatment, or cure of a disease or condition in human beings. LNC Therapeutics has opted to develop single strain live biotherapeutic products, which use a single strain of bacteria selected specifically for each drug candidate.

• First biotech company to harness the therapeutic potential of the Christensenella gut bacteria in mood disorders
• Strengthens portfolio of intellectual property and Live Biotherapeutic Products for new applications in areas of high unmet medical need

Bordeaux, France, April 15th, 2020 – LNC Therapeutics, a French biotech company specializing in the research and development of innovative drugs harnessing the potential of the gut microbiome, announced today that it entered into an exclusive license agreement with Spanish National Research Council (CSIC), for its patent dedicated to the therapeutic applications of Christensenella gut bacteria in mood disorders.

The acquisition of this licence grants LNC Therapeutics the exclusive worldwide research, manufacturing and marketing rights of the therapeutics developed for the treatment of mood disorders, such as depression or anxiety. This agreement is based on the work of the research team led by Prof. Yolanda Sanz, Professor of Research and Head of the “Microbial Ecology, Nutrition and Health” group at the Institute of Agrochemistry and Food Technology (IATA) of the Spanish National Research Council (CSIC), Spain, as well as the lead investigator of the European MyNewGut project, one of the world’s largest microbiome research initiatives conducted so far.

The unique gut-brain connection: a new treatment approach to mood disorders identified by LNC Therapeutics

The gut has its own neural network, the enteric nervous system, which alone contains over 500 million neurons and is connected directly to the brain via the vagus nerve. Research on this bidirectional communication system, known as the gut-brain axis, is a fast-growing field. It is now clear that the gut affects the brain, and numerous studies confirmed the role of the intestinal microbiota on neurodegenerative diseases and mood disorders. Targeting the gut microbiome offers promising new therapeutic approaches in neurological and mental disorders.

As a keystone of the gut microbiome, the Christensenellaceae family of bacteria promises to be an important source of treatment innovations. It enables exploration of a new avenue of research in the treatment of chronic conditions, such as obesity or metabolic and inflammatory diseases. In addition, LNC Therapeutics’ focus on the beneficial properties of Christensenellaceae, extended to targeting the gut-brain axis for the treatment of mood disorders, will pave the way for new and promising applications.

“The conclusion of this agreement with a leader in the discovery of the gut microbiome’s therapeutic applications such as LNC Therapeutics reinforces our belief about the potential advantages of the bacteria Christensenella in human health. The fundamental role played by the gut and its microbiota in the functions of our central nervous system is still a field of research in development, and I am convinced that this new research program will allow us to quickly identify new therapeutics properties specific to a bacterial strain of Christensenella for mood disorders. “ said Pr. Yolanda Sanz.

“We are pleased to announce today the acquisition of this new licence that broadens the applications of our Live Biotherapeutic Products to mood disorders, which is an area of high unmet medical needs,” concluded Georges Rawadi, CEO of LNC Therapeutics. “The gut-brain axis is certainly one of the most innovative area in drug discovery today, and it is an exciting opportunity for LNC Therapeutics to leverage our expertise in preclinical, manufacturing and regulatory activities to develop first in class products in that field”.