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WESTON, Fla. - ZyVersa Therapeutics, Inc. (Nasdaq:ZVSA), a micro-cap biotech company with a market capitalization of $1.22 million, has initiated a phase 2a clinical trial of its Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease (DKD), with the first patient expected to begin therapy by the end of the current quarter. According to InvestingPro data, the company maintains a positive cash position relative to debt, though its overall financial health score indicates challenges ahead.
The clinical-stage biopharmaceutical company is developing VAR 200 to address kidney lipotoxicity, a condition where excess lipids accumulate in kidney cells, triggering inflammation and fibrosis that lead to progressive kidney damage. Despite the stock’s significant decline of over 94% in the past year, analysts maintain an optimistic price target of $20, according to InvestingPro data.
According to research highlighted by ZyVersa, diabetes-associated metabolic issues cause abnormal lipid metabolism in kidney cells. This process is characterized by increased fatty acid release, excessive lipid production, impaired cholesterol removal, and reduced ability to break down stored lipids.
The company reports that impaired cholesterol efflux is particularly damaging to podocytes, key components of the kidney’s filtration system, resulting in structural damage and protein leakage into urine.
"We are hopeful that by alleviating lipotoxicity with VAR 200, kidney injury and disease progression will be reduced," said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, in the press release.
VAR 200 works by directly removing cholesterol and lipids from kidney cells while upregulating cholesterol transporters ABCA1 and ABCG1 for active removal.
The company plans to provide initial data from the phase 2a trial in the second half of 2025. ZyVersa also intends to study VAR 200 in patients with rare kidney diseases, including focal segmental glomerulosclerosis (FSGS) and Alport Syndrome.
Currently, over 130,000 patients with kidney disease progress to renal failure annually in the US, with more than 800,000 patients requiring dialysis or transplant. The global drug market for kidney diseases was $18 billion in 2024, with projections reaching $30 billion by 2034, according to data cited in the company’s statement. For investors interested in deeper analysis of biotech opportunities like ZVSA, InvestingPro offers comprehensive financial health metrics and 15+ additional exclusive insights about the company’s performance and potential.
In other recent news, ZyVersa Therapeutics has been actively progressing its clinical and financial strategies. The company secured $12 million in financing to support its research and development efforts focused on kidney and inflammatory diseases. This funding includes a $2 million warrant inducement transaction and a $10 million Share Purchase Agreement with Williamsburg Venture Holdings. ZyVersa’s investigational drug, VAR 200, received FDA authorization for Emergency Compassionate Use to treat a patient with the rare kidney condition ApoCII amyloidosis. The company has also initiated patient recruitment for a Phase 2a study of VAR 200 aimed at treating diabetic kidney disease, with the first clinical site now active in San Antonio, Texas. Additionally, ZyVersa’s stock will transition to the OTCQB Venture Market following a decision by the Nasdaq Hearings Panel to deny its appeal to remain on the Nasdaq Capital Market. This decision followed the company’s noncompliance with the minimum bid price requirement. Despite this, ZyVersa continues to advance its therapeutic programs and expand its market presence.
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