ABIONYX Pharma has completed a successful pre-IND meeting with the FDA for CER-001 Phase 2b/3 Clinical Trial for Patients with Sepsis

• Based on encouraging Phase 2a data and a productive pre-IND Type B meeting with U.S. Food and Drug Administration (FDA), ABIONYX Pharma intends to file an Investigational New Drug application (IND) in the coming months which will include a Phase 2b/3 clinical trial for CER-001 in Sepsis

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TOULOUSE, France & LAKELAND, Mich.--(BUSINESS WIRE)-- ABIONYX Pharma, (FR0012616852 - ABNX - eligible for PEA PME), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today announced that the company has completed a pre-IND (Investigational New Drug Application, IND) meeting with the US Food and Drug Administration and has received feedback to support an IND filing for its candidate drug. This is an important validation of the quality of the project and a significant step towards an application to include American study centers in future clinical trials. ABIONYX Pharma intends to file an IND application to the US authority in the coming months.

About ABIONYX Pharma

ABIONYX Pharma is a next-generation biotech company focused on developing innovative medicines for diseases where there is no effective or existing treatment, even the rarest ones. The company expedites the development of novel therapeutics through an extensive expertise in lipid science and a differentiated apoA-I-based technology platform. ABIONYX Pharma is committed to radically improving treatment outcomes in Sepsis and critical care.

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