• Based on promising data from its Phase 2a study and a successful meeting with the Food and Drug Administration (FDA), ABIONYX Pharma will file an IND application in the coming months, with a view to initiating a phase 2b/3 clinical study evaluating CER-001 in the treatment of patients with sepsis
Toulouse, FRANCE, Lakeland, UNITED STATES, June 13, 2024, 7:00 p.m. CEST – ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME eligible), next generation biotechnology company dedicated to the discovery and development of innovative therapies based on only recombinant human apolipoprotein apoA-I in the world, today announces that it has successfully passed the pre-IND (Investigational New Drug Application) meeting with the US Food and Drug Administration and has received favorable feedback for the filing of an IND for its drug candidate. This is an important validation of the quality of the project and a significant step towards requesting inclusion of US study centers in future clinical studies. ABIONYX Pharma plans to file an IND application with the American health authority in the coming months.
To receive information from ABIONYX Pharma in real time, send a request to [email protected].