In silico clinical trials pioneer Novadiscovery SA has raised €5m in a series A financing led by Swiss Debiopharm Innovation Fund.
French in silico clinical trial specialist Novadiscovery said it will use the €5m tranche of a €7m Series A funding round with Debiopharm Innovation Fund SA to scale its in silico clinical trial simulation platform Jinkō® from a consulting to software as a service (SaaS) model, which is compliant with FDA priorities and requirements. Novadiscovery pioneers the use of in silico clinical trials prior to human drug testing to predict drug efficacy and optimize clinical trail design. Several hundred disease and disease subtype-specific parameters are combined in the company's in silico models that mimic the physiology and co-morbidities of virtual patients.
Knowledge-based in silico modelling of clinical trials holds the potential to predict outcomes and optimise the design of clinical trials with the aim to reduce research & development (R&D) costs and time-to-market of novel drugs. Most recently, Novadiscovery accurately modelled the Phase I outcomes of the FXR agonist EYP001 in healthy and subjects infected with the hepatitis B virus (HBX) in a Phase I study. Furthermore, Jinkō® was used to predict Phase II outcomes of a combination of EYP001 with standard therapy.
The Computational Model integrates 300+ biological variables and 600+ parameters. With seven mechanistic submodels (including the effect of FXR agonist on HBV replication, HBV excretion, bile acid physiology and EYP001, ETV, and pegylated interferon drug models), the model has been used to predict quantitative efficacy of treatments on disease-related endpoints (eg. plasma HBV DNA and HBsAg concentrations) in a virtual population. All the submodels are ultimately combined into a multi-scale Computational Model simulating the dynamics of biological entities at the molecular, cellular and organ levels.
“We have seen the significant positive impact our in silico trials platform can have on reducing R&D costs and compressing time-to-market for new drugs and in drug repositioning,” stressed François-Henri Boissel, CEO and Co-Founder of Nova. “This funding allows us to accelerate the development of our platform in a SaaS model that will make it available to a growing number of clients and project, notably in the US. We intend to complete the €7m Series A in 2020.”
Reducing R&D costs and time-to-market has become a key strategic objective for healthcare companies and payors. The in silico trial market is evaluated to grow to $2,88bn in annual revenue by 2022, when it will still represent only a small fraction of $165bn annual drug R&D spent.
Reducing number of “real” patients involved in clinical trials is also a main issue, for both the industry and the regulators. Because they are not so many considering the number of drugs to be evaluated, and their participation in a clinical trial must be as ethical as possible. Nova’s unique hybrid approach to running in silico clinical trials presents several benefits, one of which being that it can operate in data-poor environments, which is the biggest hurdle more conventional artificial intelligence (AI)-based approaches are facing.