Genfit provided an update on the impact of the coronavirus on its business. First, the Phase 3 clinical trial in Nash (non-alcoholic steatohepatitis) with fibrosis “Resolve-It” continues. The biotech company is awaiting comments from the FDA, and their integration for the continuation of the study. According to the French group, the health crisis should not cause a significant delay in receiving these comments.
After careful consideration of the potential benefit of continued treatment for Nash patients, Genfit has also decided to continue the extension phase of the study. The group has, of course, taken all necessary safety measures to undergo these studies.
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Some trials have been suspended due to the coronavirus pandemic
Genfit has discontinued, as recommended, all Phase 1 trials – including pharmacokinetics, food interaction and bioequivalence trials. These studies are necessary for the filing of a New Drug Application (NDA) for elafibranor in Nash.
Patient enrollment for a pediatric Nash trial and a Phase 2 liver lipid composition trial have also been suspended.
While its program in primary biliary cholangitis (PBC) and combination therapy program in Nash continues, with several projects underway, Genefit has decided to suspend the initiation of its Phase 2 trial in combination with treatment and the initiation of its Phase 3 trial in PBC patients.
All support activities related to the continuation of ongoing studies, or the initiation of new studies, will be maintained in order to minimize potential delays when the epidemic crisis ends.
Genfit will continue the clinical research
Genfit’s diagnostic solution continues to be deployed in clinical research. Despite a high level of interest in NIS4, the use of the test may be curtailed due to potential delays encountered by some NIS4 clients as a result of the COVID-19 pandemic. The French biotech teams are moving forward in parallel with the In Vitro Diagnostic (IVD) part of the program.
Furthermore, Genfit does not anticipate any disruption in supplies for its ongoing or planned clinical trials at this stage. The Company has sufficient elafibranor inventory available for all of its clinical studies through mid-2021 and does not anticipate any disruption in raw material inventories or commercial batch production.
Similarly, its partners and teams have continuity plans in place to ensure the operational management of ongoing and planned trials, including under current conditions.
The FDA is the health authority in the US to grant market authorizations
Among the responsibilities of the Food and Drug Administration (the health authority in the United States) is the granting of marketing authorizations for all medicines intended for the United States, which represents the world’s largest market for the pharmaceutical industry.
Phase I refers to small-scale testing of the molecule in humans to evaluate its safety, tolerance, metabolic and pharmacological properties. Phase II refers to the evaluation of tolerance and efficacy in several hundred patients to identify side effects. Phase III represents the evaluation of the overall benefit/risk ratio in several thousand patients.
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