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OBEMINALE 2 clinical trial

LNC Therapeutics launches OBEMINALE 2 clinical trial

Stablor is a medical nutrition product that addresses a major public health issue, obesity. Its composition, protected by international patents, combines specific fractions of milk proteins with selected amino acids

LNC Therapeutics, a French biotech company specialized in the gut microbiome-based drug discovery, has announced the launch of a new clinical trial with Stablor, OBEMINALE 2, and the treatment of the first patient. This new clinical study is intended to obtain 13.5 health claim from the European Food Safety Authority, EFSA. The final results are expected in the fourth quarter of 2019.

Stablor is a medical nutrition product that addresses a major public health issue, obesity. Its composition, protected by international patents, combines specific fractions of milk proteins with selected amino acids. What is unique about Stablor is its ability to target the metabolic and nutritional disorders linked to obesity, the company claims.

A first clinical trial, OBEMINALE 1, completed by LNC, has demonstrated the clinical efficacy of Stablor on visceral fat loss and cardio metabolic risk factors in obese patients with a metabolic syndrome. The trial also highlighted the ability of Stablor to modulate gut microbiome and more specifically, a family of bacteria known for its anti-obesity potential.

OBEMINALE 2 is a confirmatory study that aims to obtain an EFSA 13.5 health claim for Stablor. This EFSA health claim is based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data by the sponsor. OBEMINALE 2 study was designed according to the pharmaceutical industry’s standards (including multi-centre, randomised, double-blind, placebo) and will enrol 240 obese patients with a metabolic syndrome.

The company has also signed an exclusive license agreement with Cornell University for its Christensenella patent family. Christensenellais a recently discovered family of gut bacteria. Considered a keystone taxon in the human gut microbiome, it represents a major opportunity in the fight against obesity, metabolic disorders and other high-impact diseases. Christensenella and microbiome modulation is an innovative approach with the potential to unlock a wide range of therapeutic applications.

By securing a license for the Christensenella patent, LNC has bolstered its strategy for developing innovative therapeutic approaches based on this new family of bacteria.

"Expanding our intellectual property is essential in order for us to successfully pursue our vision and our development strategy," said Dr Georges Rawadi, CEO of LNC. "Securing a license for the Christensenella patent has reinforced our existing intellectual property portfolio. It's a key step in establishing our leadership position for the Christensenella family and anticipating its future therapeutic applications."

LNC aims to use this license to develop the first Christensenella-based drug candidate for the treatment of obesity and metabolic disorders. In parallel, LNC will leverage its research platform dedicated to studying this family of bacteria in order to gain deeper insight into how it operates and understand how it interacts with host cells.

"We strongly believe that Christensenella has a wide therapeutic potential that goes beyond obesity and metabolic disorders. We are therefore considering the possibility of broadening our fields of application," Rawadi added.

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