Development program

Stablor®
program

Overview

Stablor® is our most advanced program in terms of development. After completing the current clinical trial, LNC Therapeutics will use these data to obtaining an European Food Safety Authority (EFSA) 13(5) health claim for Stablor®.

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Protected by international patents, Stablor® composition combines specific fractions of milk proteins with selected amino acids. Stablor®’s specificity lies in the fact that it targets obesity-related metabolic and nutritional disorders of obese patients with metabolic syndrome (increased waist size associated with 2 other metabolic disease risk factors).

Mode of action

Today, LNC scientific team has developed a clear understanding of the mode of action of Stablor® in targeting visceral fat and improving metabolic markers in obese patients.

POC in Human

OBEMINALE 1 was the first clinical trial run on Stablor®. The objective was to assess the impact on visceral fat loss and cardiometabolic risk factors in overweight or obese patients with metabolic syndrome. During a moderate caloric restriction while maintaining a balanced diet OBEMINALE 1 was a multi-center, randomized, double-blind, placebo-controlled study carried out on a population of 120 patients (60 in the Stablor® group, 60 in the comparator group).

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This trial demonstrated Stablor®’s clinical efficacy in significantly reducing visceral fat loss, as well as other metabolic markers.

In addition, OBEMINALE 1 allowed to point out Stablor® as a modulator of gut microbiome through the promotion if a specific family of bacteria known for its anti-obesity potential. This has been a major breakthrough and a driving force behind LNC Therapeutics’s strategy.

Targeting EFSA approval

Building on the promising results of OBEMINALE 1, a confirmatory study – dubbed OBEMINALE 2 – was launched in 2018.

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The OBEMINALE 2 trial was developed in accordance with pharmaceutical industry standards (multi-center, randomized, double-blind, placebo-controlled) and targets 240 obese patients with metabolic syndrome.

The trial launch and treatment of the first patient were announced in October 2018. The final results are expected to be available by the end of 2019.

EFSA 13(5) health claims are based on newly established scientific evidence and include an application to protect data relating to the applicant’s exclusive property.

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Stablor® program?

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LNC01
program

Overview

LNC01 is a development project aiming at harnessing the potential of Christensenella minuta (C.minuta) as a novel therapy to treating obesity and metabolic disorders. We will bring the first therapeutic Live Biotherapeutic Product (LBP) based on C. minuta to clinical development.

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Our program is built on first-class scientific publications that have identified Christensenella to be a cornerstone of healthy human intestinal microbiota. We have also secured a strong IP position in this field to successfully pursue our vision and our development strategy

LNC Therapeutics is currently considering obesity and associated metabolic disorders as the lead indication because this is where a causal relationship between C. minuta and health have been established.

Why Christensenella ?

Since its discovery in 2012, the christensenella group of gut bacteria has continuously demonstrated high potential in the field of human health.

LNC Therapeutics, is the first company to harness the therapeutic potential of christensenella

 

6 highlights on research progress

C. minuta was discovered in 2012 by Professor Masami Morotomi (Yakult Central Institute for Microbiological Research, Japan) who isolated the small micro-organism from a healthy human donor.

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In 2014, it was identified as the most heritable bacterial taxon in humans and was found to be significantly reduced in obese European individuals (Goodrich et al. 2014).

These observations were rapidly confirmed in an independent study in 2015 (Fu et al. 2015). In addition, high levels of C. minuta in the 2015 cohort were associated with reduced circulating levels of triglycerides and higher HDL cholesterol (also known as “good” cholesterol).

Disappearance of C. minuta bacteria has since been associated with other conditions such as inflammatory bowel disease (Pascal et al. 2017, Kummen et al. 2017, Zakrzewski et al. 2018).

Although many questions remain to be explored, it was strongly demonstrated that Christensenella plays a major role in the development of a healthy intestinal microbiome and is absent in many pathological situations. Thus, it bears potential to be a source of innovative treatment for multiple diseases.

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Today, LNC Therapeutics is a pioneer in the use of christensenella’s therapeutic potential. We envision the use of the living bacteria formulated in a pill or the metabolites it secretes for the development of these new therapies.

These Live Biotherapeutics Products (LBPs) are a new class of drugs that emerged with the recent development of the microbiome field. We designed our LBP program to address the challenges associated with LBP development. LNC owns a pool of proprietary bacteria strains selected to become as a suitable drug. We are in the process of developing scale-up for manufacturing and still have established a regulatory strategy to submit a Clinical Trial Application for First-in-Men in the near future.

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LNC01 program?

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investments programs
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Microbiome & us
News
Nov 22, 2019
We are looking for preclinical project manager | WHAT WE OFFER An exciting opportunity to dive in and begin your career...
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Nov 5, 2019
LNC Therapeutics Announces Formation of its Scientific Advisory Board | Appoints international experts with...
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Press / Media
Nov 12, 2019
Biotechs investments disrupt Big Pharma business model The pharmaceutical industry is in a state of flux, with...
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Sep 6, 2019
Chaque semaine, Maddyness dresse le bilan des levées de fonds de la semaine qui vient de s’écouler. Cette semaine,...
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Publications
Jan 11, 2019
Comparison of the Gut Microbiota of Centenarians in Longevity Villages of South Korea with Those of Other Age Groups...
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Jan 2, 2019
Gut Microbes and Health: A Focus on the Mechanisms Linking Microbes, Obesity, and Related Disorders   Marialetizia...
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