ZyVersa Backs FDA-Authorized Emergency Compassionate Use of Cholesterol Efflux Mediator VAR 200 in Patient with ApoCII Amyloidosis

July 8, 2025

DENVER, Colo., Jul 08, 2025 (247marketnews.com)- ZyVersa (NASDAQ:ZVSA) announced its support for the FDA-authorized Emergency Compassionate Use of its investigational drug Cholesterol Efflux Mediator VAR 200 in a patient diagnosed with ApoCII amyloidosis, a rare, life-threatening condition with no effective treatment alternatives.

The treatment will be administered at the University of Miami Peggy and Harold Katz Family Drug Discovery Center, led by Dr. Alessia Fornoni, Professor of Medicine at the University of Miami Miller School of Medicine and the inventor of VAR 200. The compassionate use will follow the dosing and monitoring protocol of ZyVersa’s ongoing Phase 2a clinical trial in diabetic kidney disease (DKD), designated as VAR200-0301 (ClinicalTrials.gov ID: NCT06489340).

Emergency Compassionate Use is a regulatory pathway that allows patients facing serious or immediately life-threatening conditions to access investigational therapies when clinical trial eligibility cannot be met and no comparable options exist.

“We are at a time where Precision Medicine offers new tools to endophenotype patients and to identify the molecular signature that allows us to match the right patient to the right drug. The evidence of lipotoxic glomerular injury in this patient is what prompted me to request emergency compassionate use. I am very excited about the opportunity to test the efficacy of VAR 200 for this new indication, as I believe experimental treatment cases like this one will drive further clinical development for other patients as well,” said Dr. Fornoni.

About VAR 200: Cholesterol Efflux Mediator

VAR 200 (2-hydroxypropyl-beta-cyclodextrin, or 2HPβCD) is ZyVersa’s novel, injectable Cholesterol Efflux Mediator in Phase 2 development for the treatment of rare and serious kidney disorders. Designed to reduce lipid accumulation in the kidneys, VAR 200 works both passively and by activating cholesterol efflux transporters ABCA1 and ABCG, thereby helping to restore and preserve kidney filtration function.

In preclinical studies, VAR 200 has shown promise in models of focal segmental glomerulosclerosis (FSGS), Alport syndrome, and diabetic kidney disease (DKD). The therapy was associated with:

  • Reduced cholesterol and lipid levels
  • Protection against renal injury and fibrosis
  • Improvements in proteinuria, a key clinical marker of kidney function

While FSGS is the lead indication, ZyVersa has initiated a Phase 2a trial in DKD to gain more rapid clinical proof-of-concept. Based on results, the Company plans to expand indications to include Alport Syndrome and other lipid-driven renal disorders.

For more scientific background, download the VAR 200 White Paper available on ZyVersa’s website.

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