Bordeaux, October 1st, 2018 – LNC Therapeutics, a French biotech company specialized in the gut microbiome-based drug discovery, today 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.
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-center, randomized, double-blind, placebo) and will enroll 240 obese patients with a metabolic syndrome. LNC today announced the start of the study and the treatment of the first patient. The final results are expected by the end of 2019.
“Stablor® is a unique product that addresses a market with a very high potential. Demonstrating its safety and efficacy through two independent clinical trials will allow us to seek regulatory approval for a health claim. This approach maximizes the value of our product,” says Dr. Georges Rawadi, CEO of LNC Therapeutics. “As a biotechnology company, our field of activity is research and development and not commercialisation. We are therefore exploring the opportunity to partner Stablor® with one or more commercial organization who could bring our product to market.”
For more information about OBEMINALE 1: https://clinicaltrials.gov/ct2/show/NCT01755104