ABIONYX Pharma RACERS Study Clinical Results in Brain-Fog Selected for Poster Presentation at the American Society of Nephrology (ASN) 2024 Annual Meeting "Kidney Week"

New clinical data showed positive impact on cognitive impairment

Validation of efficacy of CER-001 in brain-fog and support for exploring new indications in neuroinflammation

Regulatory News:

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’s Phase 2b RACERS study in sepsis has been selected again as a poster presentation in the “AKI: Clinical, Outcome, and Trials- Epidemiology and Pathophysiology” poster session at the 2024 American Society of Nephrology Annual Meeting taking place October 23-27, 2024 in San Diego, California.

The poster data will reveal exclusive new clinical results in brain-fog. CER-001 mitigates brain dysfunction by downregulating the Indolamine-2,3- dioxygenase 1 (IDO1) enzyme, a crucial mediator of the kynurenine pathway (KP) in sepsis. The IDO1 is significantly upregulated during inflammation and this has been linked to cognitive dysfunction.

RACERS new clinical data suggest that IDO-1 is downregulated after treatment, thus reducing the production of potential neurotoxic metabolites. Clinical results showed significantly increased levels of tryptophan during treatment (p=0.0037), accompanied by observed increases in the neuroprotective Kynurenic Acid (KYNA), supporting the hypothesis of different regulation of tryptophan metabolism leading to neuroprotection.

Pr. Loreto Gesualdo, Head of the Nephrology, Dialysis and Transplantation Unit, University of Bari Aldo Moro, Italy, and lead investigator of the RACERS study, stated: “We are thrilled to present new clinical results at ASN Kidney Week in 2024. In RACERS clinical study, CER-001 treatment attenuated systemic inflammation, downregulated IDO1, thereby reduces neuroactive metabolites and waste accumulation. CER-001 may have the potential to enhance cognitive functions in sepsis patients. Those results confirm RACERS robust data in patients and the efficacy of CER-001. The new data validate the potential of the bio drug in treating brain-fog in sepsis, but also support the exploration of additional indications for CER-001 in neuroinflammation.”

The schedule for ABIONYX presentation is as follows:

Poster Session: “AKI: Clinical, Outcome, and Trials- Epidemiology and Pathophysiology”, 10:00 am EDT, October 24, 2024, Exhibit Hall

Poster Title: Brain-Kidney Interplay during Sepsis- Associated AKI: Results from the RACERS Study

Poster #: TH-PO064

The poster will be available on the ASN website starting, October 24, 2024, at 10.00 am EDT.

About CER-001

CER-001 is an engineered HDL particle which contains recombinant human apolipoprotein A-I (apoA-I), complexed with phospholipids. HDL particles have been shown to be highly effective scavengers of bacterial endotoxins, such as lipopolysaccharide (LPS), with the ability to inactivate LPS and target it for removal by the liver. In addition, its significant capacity to uptake cholesterol and lipids accumulated in tissues (particularly kidneys) makes CER-001 a important tool in the treatment of Norum disease.

About ABIONYX Pharma

ABIONYX Pharma is a new generation biotech company that aims to contribute to health through innovative therapies in indications where there is no effective or existing treatment, even the rarest ones. Thanks to its partners in research, medicine, biopharmaceuticals and shareholding, the company innovates on a daily basis to propose drugs for the treatment of renal and ophthalmological diseases, or new HDL vectors used for targeted drug delivery.

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