ABIONYX Pharma Completes Successful Pre-IND Meeting with FDA for CER-001 Phase 2b/3 Sepsis Trial

ABIONYX Pharma, a biotechnology company based in Toulouse, France, and Lakeland, Michigan, has recently announced a significant milestone in its drug development program. The company, which is listed on the stock exchange under the code FR0012616852 (ABNX) and is eligible for PEA PME, specializes in creating innovative therapies derived from the world’s only natural recombinant apoA-I. This announcement comes after a successful pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), which yielded positive feedback, reinforcing the quality of ABIONYX Pharma's project and paving the way for an IND filing in upcoming months.

ABIONYX Pharma is dedicated to the discovery and development of new-age medications that address diseases with no existing or effective treatments, including some of the rarest medical conditions. The company leverages extensive expertise in lipid science and a unique apoA-I-based technology to speed up the development of novel therapeutics. Currently, the primary focus of ABIONYX Pharma's research and development efforts is in the fields of Sepsis and critical care, where traditional treatment options are often limited or ineffective.

The company’s Phase 2a data has been promising, and this, coupled with the productive pre-IND Type B meeting with the FDA, has provided the necessary impetus for ABIONYX Pharma to proceed with an IND application. The forthcoming IND filing will include a Phase 2b/3 clinical trial for their candidate drug CER-001, specifically targeting Sepsis.

This recent development marks a pivotal step for ABIONYX Pharma, as it aims to include American study centers in its future clinical trials. The completion of the pre-IND meeting and the positive feedback from the FDA not only validate the quality and potential of ABIONYX Pharma’s drug but also bring the company closer to its goal of improving treatment outcomes in Sepsis and critical care.

In summary, ABIONYX Pharma's advancement towards an IND application is a testament to its commitment to pioneering innovative treatments for some of the most challenging and unmet medical needs. With a clear focus on Sepsis and critical care, the company's progress represents a significant stride in the realm of biotechnology and pharmaceutical development.