ZyVersa Therapeutics Backs Emergency Use of Investigational Kidney Drug VAR 200 for Ultra-Rare ApoCII Amyloidosis Case

Patient with progressive kidney disease receives FDA-authorized compassionate use of VAR 200 under care of University of Miami nephrologist and drug inventor

ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA), a clinical-stage biopharmaceutical company focused on first-in-class treatments for renal and inflammatory diseases, announced its support for the FDA-authorized Emergency Compassionate Use of its investigational drug, VAR 200, in a patient suffering from ApoCII amyloidosis, an ultra-rare and life-threatening condition with limited treatment options.

ApoCII amyloidosis is characterized by toxic fibrillar amyloid deposits that predominantly affect the kidneys, leading to proteinuria and chronic kidney disease. Despite receiving standard-of-care therapy including ACE inhibitors, SGLT2 inhibitors, statins, and ezetimibe, the patient's condition continued to decline. A kidney biopsy revealed lipid accumulation, prompting Dr. Alessia Fornoni--Director of the Peggy and Harold Katz Family Drug Discovery Center at the University of Miami and inventor of VAR 200--to request compassionate use of the drug.

VAR 200, ZyVersa's Cholesterol Efflux Mediator(TM), is currently being evaluated in a Phase 2a clinical trial (NCT06489340) for diabetic kidney disease (DKD). It is designed to reduce lipid accumulation in the kidneys, thereby protecting against injury and fibrosis while improving kidney function. The drug has shown consistent efficacy in preclinical models of kidney disease and is supported by clinical data from related lysosomal storage and protein deposition disorders.

"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," said Dr. Fornoni. "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."

Treatment of the patient will follow the DKD trial protocol and will be closely monitored at the University of Miami. ZyVersa expressed optimism about the potential benefits of VAR 200 in this setting.

"We are proud to support Dr. Fornoni's Emergency Compassionate Use of VAR 200 in her patient with ApoCII amyloidosis who currently has no other effective treatment options," said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. "We are hopeful that VAR 200 will help to improve the course of her disease and quality of life. The insights gained from this case, combined with data from our Phase 2a trial, will help guide the continued development of VAR 200."

Emergency Compassionate Use--also known as Emergency Expanded Access--allows patients with serious or life-threatening conditions to access investigational treatments outside of clinical trials when no comparable alternatives exist.

As ZyVersa continues advancing its pipeline, this case could help open the door for broader applications of VAR 200 in rare renal disorders beyond DKD.

The post ZyVersa Therapeutics Backs Emergency Use of Investigational Kidney Drug VAR 200 for Ultra-Rare ApoCII Amyloidosis Case appeared first on PRISM MarketView.

COMTEX_467110595/2927/2025-07-08T12:01:35