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LNC Therapeutics Receives FDA Investigational New Drug Approval to Initiate a Phase 1 Clinical Trial on Xla1 for the Treatment of Obesity and Metabolic Diseases

Sep 8, 2020
  • 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.”

 

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.

 

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 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.

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