YSOPIA Bioscience

• 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”.

• Xla1 is a first-in-class, orally bioavailable single strain Live Biotherapeutic Product (LBP)
• Single strain Live Biotherapeutic Products are a new class of drugs developed by LNC Therapeutics to restore the gut microbiome’s deficient functions by using the therapeutic properties of Christensenella, a unique keystone bacteria strain

Bordeaux, France, September 08th, 2020 – LNC Therapeutics, a French biotech company harnessing the properties of keystone single-strain bacteria to develop ground-breaking microbiome-based drugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Xla1, the Company’s lead candidate being evaluated for the treatment of obesity and metabolic disorders.

Xla1 is a first-in-class, oral capsule treatment, using a live single bacterial strain of Christensenella minuta. With an active IND and the clinical c-GMP batch available, LNC Therapeutics is planning to assess the safety and tolerability of Xla1 in adults with obesity and metabolic abnormalities in a Phase 1 clinical trial in the US.

Christensenella is a keystone bacteria of healthy human gut microbiome. Since its discovery in 2012, the Christensenellaceae family has demonstrated a strong potential in obesity and metabolic diseases prevention in multiple scientific publications over Europe, America and Asia. Its absence is a key factor in the development of obesity and metabolic disorders. In fact, the relative abundance of Christensenella in the human gut is inversely related to host body mass index (BMI) and to the presence of several metabolic disease markers.

Xla1 has been selected  from LNC Therapeutics proprietary bacterial strain library  following a rigorous screening process. Furthermore, proof of concept studies in preclinical models have demonstrated the substantial efficacy of Xla1 on obesity and related metabolic markers.

As the first biotech company to explore the possibilities offered by Christensenella in human health, LNC Therapeutics paves the way toward a new therapeutic hope for obese patients.

“Based on the strong efficacy results from our preclinical studies, we believe our clinical candidate, Xla1, has broad potential for the treatment of patients with obesity and associated metabolic disorders.The FDA’s approval of our IND represents a major milestone in transitioning from a preclinical to a clinical-stage biotechnology company,” said Dr. Georges Rawadi, CEO of LNC Therapeutics. “We are very excited to move one step closer to bringing innovative single-strain microbiome-based therapies to address a large area of unmet medical need.”

• YSOPIA Bioscience received approval in early September 2020 of its clinical trial application (IND) to launch a Phase 1 trial in obesity and associated metabolic diseases
• 4 development programs for innovative drugs candidates based on the potential of key bacteria of the gut microbiome in human health
• YSOPIA Bioscience will carry on the development of its Live Biotherapeutics Products (LBP), a new class of drugs targeting chronic diseases with high unmet medical needs

Bordeaux, France, September 29th, 2020 – LNC Therapeutics, a French biotech company harnessing the properties of keystone single-strain bacteria to develop ground-breaking microbiome-based drugs, announced today changing its name to YSOPIA Bioscience.

Founded in 2010 to address the root causes of obesity and associated metabolic disorders, the Company quickly centered its Research & Development activities on the promising path of the gut microbiome.

Since 2018, the Company has been focusing on the development of a portfolio of innovative drugs derived from the microbiome using the unique properties of single strain bacteria. YSOPIA Bioscience targets more specifically a group of keystone bacteria essential to human health: christensenella. The Company is also extending its field of application to several other chronic indications with a strong need for breakthrough therapeutic innovations.

Following the recent approval by the U.S. FDA of its clinical trial application (IND) in obesity and associated metabolic diseases, this name change marks YSOPIA Bioscience’s development strategy and its transition to a clinical stage biotechnology company.

“This new name, YSOPIA Bioscience, symbolizes the major success of our teams in advancing to the clinic, in line with our ambition to become a major player in therapies based on the gut microbiome properties. We are now on the edge of beginning the studies that will evaluate the therapeutic potential of our technology. Above all, we strive to demonstrate the efficacy of Christensenella bacteria in human health in order to offer, as soon as possible, a therapeutic solution to patients suffering from chronic pathologies, for which there is currently no effective treatment,“commented Dr. Georges Rawadi, CEO of YSOPIA Bioscience.

The meaning of YSOPIA:

This new name was inspired by Ancient Greece, a time when many of the fundamentals of modern medicine were born. In particular, it refers to Epione, the goddess soothing pain in Greek mythology. In addition, YSOPIA is inspired by the Greek word for balance, an essential characteristic of a healthy intestinal microbiome, which contributes to its proper functioning and positive impact on human health.