ABIONYX Acknowledges Results of Phase 3 Study Evaluating CSL112
ABIONYX Pharma Announces Its Strategy in Ophthalmology and New Positive Preclinical Results for the Deployment of Two Innovative Technology Platforms: Apotherapy and Biovectorization
Abionyx Pharma has hailed the success of a phase 2a clinical trial designed to resurrect a cholesterol drug that first flamed out almost a decade ago. But with the French biotech yet to share numbers from the study, it is unclear whether the mimic of HDL cholesterol has a future in the treatment of septic patients.
Abionyx Pharma has reported that its Phase IIa pilot clinical trial of CER-001 to treat septic patients who are at increased risk of developing acute kidney injury (AKI) met its primary goal.
ABIONYX Pharma Reports Positive Results from Phase 2a Pilot Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing Acute Kidney Injury
ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, today reported positive interim results of an open-label Phase 2a clinical trial evaluating CER-001 as a treatment for septic patients at high risk of developing Acute Kidney Injury (AKI).
ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible) (Paris:ABNX), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to the Bio-HDL CER-001 for the treatment of lecithin-cholesterol acyltransferase (LCAT) deficiency. The designation covers both partial LCAT deficiency, presenting as Fisheye Disease, and complete LCAT deficiency presenting with renal symptoms and corneal opacities. Progression of LCAT deficiency, for which there is no approved treatment, can ultimately lead to renal failure requiring dialysis or kidney transplant, and/or to complete corneal opacification requiring transplant.
TOULOUSE, France--(BUSINESS WIRE)--ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, today announces that the French Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM), granted a Compassionate Access Authorization for the bio-HDL (CER-001) in COVID-19 disease.