CURE COVID: GNS561 Phase II

The funding granted will allow phase II to be carried out for Genoscience Pharma's flagship product, GNS561 for the "CURE COVID" trial, a randomized trial against the standard of care, with 200 patients presenting mild and moderate symptoms who will be included. The rise in industrial scale for the manufacture of the active ingredient and the finished product is also covered in order to be able to set up a European supply chain for the product. GNS561 is a new molecule that has demonstrated on several strains of SARS-CoV-2 a more potent inhibition of virus replication than remdesivir and hydroxychloroquine, 10 to 1000 times stronger respectively, in in vitro cell culture models. . The unique mechanism of action through inhibition of cellular autophagy associated with GNS561, in addition to viral inhibition, a potential decrease in the inflammatory response (cytokine storm) and pulmonary fibrosis seen in many patients. The "CURE COVID" trial has been authorized by the French regulatory authority, and a submission is underway with the FDA. The funding will fully fund the Genoscience Pharma consortium (including the Center Hospitalier Universitaire de Dijon and the Pitié-Salpêtrière AP_HP hospital), in order to conduct the CURE COVID trial with GNS561 on COVID-19 patients, as well as the increase in production and additional development expenses. As soon as the French and European administrative and regulatory procedures are completed, the funding will extend over a period of 19 months and will include expenses from February 1, 2020. The funding includes 1.2 million euros in grants and 3, 1 million euros in repayable advances in the event of the success of the project that Genoscience Pharma would start repaying from 2024.GNS561 is a small molecule administered orally which inhibits the replication of the SARS-Cov2 virus at concentrations of the order of nanomolar (10-9), more potent than remdesivir on different strains of virus tested in reference laboratories French (IHU) and American (Emory University) on in vitro cell cultures. In connection with its mechanism of action, GNS561 through the inhibition of autophagy has shown a potential anti-inflammatory effect that would control the cytokine storm as well as reduce pulmonary fibrosis. Animal experiments are currently being studied, but the safety data obtained in the context of the Phase Ib / IIa trial in oncology made it possible to define a potentially active dose, lower than that used in oncology, with a margin of satisfactory security.