ABIONYX Pharma 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.

latest phase 2a clinical study with CER-001, was published by BMC Medicine, in a translational research paper that included important in-vitro data, proof of concept in a pig model of sepsis and a four-arm controlled study in patients with sepsis. All sets of data showed statistically significant effects on parameters such as endotoxin levels, key inflammatory cytokines such as IL-6 and TNF-a and endothelial markers of inflammation such as sVCAM-1, sICAM-1 and MCP-1.