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NOVADISCOVERY and ENYO Pharma sign a collaboration agreement to accelerate the clinical development of drug candidate EYP001
- The study conducted by NOVADISCOVERY is part of the exploratory clinical studies program initiated by ENYO Pharma at the end of 2016.
- It aims to enhance mechanistic and pharmacological data and to improve the design of EYP001 proof-of-concept studies, a bile-acid FXR receptor agonist currently in phase 1 trial for the treatment of Hepatitis B and NASH.
- It is based on the in silico methodology of NOVADISCOVERY which combines computational models of disease & treatment with virtual patients to predict therapeutic benefits, in real world, before human trials.
Lyon, France, October 2, 2017, 6:00 PM CEST
NOVADISCOVERY, a pioneer in in silico clinical trials, announces the signing of a collaboration agreement with ENYO Pharma. The study carried out by NOVADISCOVERY aims to accelerate and de-risk the clinical development of EYP001, a bile acid receptor agonist (the farsenoid X nuclear receptor or FXR). The latter is involved in the replication of hepatitis B virus (which exposes chronic carriers to an increased risk of cirrhosis and liver cancer) and in different hepatobiliary (such as non-alcoholic seatohepatitis or NASH), gastrointestinal and metabolic diseases.
NOVADISCOVERY will determine the dose most likely to maximize the antiviral effect of EYP001 and will select in advance the responder patient populations as well as the most effective combination therapies. To achieve this, NOVADISCOVERY will apply its WISE® (Whitebox In Silico Engine) technology platform, an open ecosystem that brings together the company’s expertise in modeling and simulation.
With WISE®, NOVADISCOVERY will develop the different pathophysiological models of interest (metabolism of bile acids, hepatic fibrosis, viral replication, immune response…), validate them on the selected patient population, identify potential gaps in knowledge and apply its proprietary methodology to predict the benefits of the drug, both at the individual and the population level.
“For biotech developers, the new in silico technologies are an invaluable decision-making support tool. They enable us to improve our knowledge on our drugs’ mechanism of action, enhance our pharmacological database and select in advance the scenario which will maximize the chances of seeing an effect for patients who take part in our clinical trials” says Dr Jacky VONDERSCHER, CEO of ENYO Pharma. ”In light of the complexity of such trials, the financial and human challenges and the inherent limits of our knowledge, we must rely on different methodologies including in silico modelling and simulation. Today NOVADISCOVERY is the only company to guarantee a complete scientific and technological integration. It is a critical point for a company that aims to develop first-in-class drugs like ENYO Pharma.”
“After the partnerships that we are developing with leaders in the oncology and immuno-oncology space, the collaboration with ENYO Pharma marks NOVADISCOVERY’s entry into the infectious and metabolic diseases markets” says François-Henri BOISSEL, CEO and co-founder of NOVADISCOVERY. “It also reflects the new stage of development reached by our company. Considering the growing interest in machine learning approaches, NOVADISCOVERY reconciles the proponents of systems biology and big data around a new approach which drives decisions based on predicted clinical benefits in real world, from the discovery of a new therapeutic target to the market authorization of the drug derived from this target. With our academic and industrial partners as well as with the European and American regulatory authorities, we are in the process of profoundly changing the drug R&D paradigm. It’s a really exciting time.”