WESTON, Fla. – ZyVersa Therapeutics, Inc. (NASDAQ: ZVSA), a biopharmaceutical company, has received Institutional Review Board (IRB) approval to proceed with a Phase 2a clinical trial for its Cholesterol Efflux Mediator VAR 200, a drug under development for the treatment of diabetic kidney disease. The trial is slated to commence in the first half of 2024.
This approval marks a significant milestone for ZyVersa, as the trial will be the first in humans for VAR 200. The drug aims to reduce renal lipid accumulation that can damage the kidneys' filtration system, potentially slowing the progression of chronic kidney disease.
The company's preclinical studies across three different animal models of kidney disease have shown that VAR 200 reduced cholesterol and lipid levels in the kidneys, protected against kidney injury and fibrosis, and significantly decreased proteinuria, which is an excess of protein in the urine.
The upcoming Phase 2a trial will evaluate the efficacy and safety of VAR 200 in patients, with the objective of confirming the positive results observed in preclinical studies. Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa, expressed optimism about the potential of VAR 200 to mitigate kidney injury and curtail the advancement of kidney disease.
Chronic kidney disease represents a significant health concern in the United States, affecting over 35 million adults. Each year, over 130,000 patients with kidney disease progress to renal failure, with more than 800,000 patients currently living with renal failure and depending on dialysis or a transplant.
ZyVersa is focused on developing first-in-class drugs for renal and inflammatory diseases with unmet medical needs. Alongside VAR 200, the company is advancing multiple programs based on two proprietary technologies, including an Inflammasome ASC Inhibitor IC 100 targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases.
This move by ZyVersa could potentially offer new treatment options for patients with diabetic kidney disease, a condition for which there is a high demand for innovative therapies. The information about the IRB approval and upcoming trial is based on a press release statement from ZyVersa Therapeutics.
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