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LNC Therapeutics Announces Successful GMP Manufacturing of Xla1 for Phase 1 Clinical Trial

Mar 12, 2020
  • 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.

 

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