ZyVersa Therapeutics Provides Regulatory And Product Support For FDA-Authorized Emergency Compassionate Use Of Cholesterol Efflux Mediator VAR 200 In ApoCII Amyloidosis Patient

Author: Benzinga Newsdesk | July 08, 2025 06:54am

• ApoCII amyloidosis, resulting from abnormal organ deposition of toxic fibrillar amyloid proteins, is an ultra-rare condition that mostly affects the kidneys and manifests with protein spillage into the urine (proteinuria) and chronic kidney disease.
• Despite being treated with standard-of-care renal drug therapy (ACEi, SGLT2, statin, and ezetimibe), the patient authorized by FDA to receive VAR 200 is showing continued kidney disease progression. Because her kidney biopsy demonstrated lipid deposition, the treating physician, Dr. Alessia Fornoni, hypothesized that VAR 200 has potential to alleviate lipid accumulation, proteinuria, and disease progression. This is based on VAR 200's consistent results across preclinical studies in three different models of kidney disease, and supporting HPβCD clinical data in patients with lysosomal storage and protein deposition disorders, such as Niemann-Pick disease type C.
• VAR 200, currently in a phase 2a clinical trial for diabetic kidney disease (DKD), was designed to passively and actively reduce renal lipid accumulation to protect against renal injury and fibrosis and improve kidney function.

WESTON, Fla., July 08, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, "ZyVersa"))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, is pleased to provide regulatory and product support for FDA-authorized Emergency Compassionate Use of Cholesterol Efflux Mediator™ VAR 200 in a patient with ApoCII amyloidosis. Emergency Compassionate Use, also called Emergency Expanded Access, is a pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational drug for treatment outside of clinical trials when enrollment criteria are not met or there are no comparable or satisfactory alternative therapy options.

The patient with ApoCII amyloidosis will receive treatment at the University of Miami Peggy and Harold Katz Family Drug Discovery Center under the care of the Center Director, Dr. Alessia Fornoni, Professor of Medicine, University of Miami Miller School of Medicine, and VAR 200 inventor. VAR 200 treatment and monitoring will follow the protocol of the ongoing DKD clinical trial, VAR200-0301

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