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WESTON, Fla. - ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA), a micro-cap biotech company with a current market value of $3.15 million, announced Thursday that it has activated its first clinical site for patient recruitment in a Phase 2a study of VAR 200, a potential treatment for diabetic kidney disease (DKD). According to InvestingPro data, the company’s stock has experienced significant volatility, with shares currently trading at $0.71, down 81% over the past year.
The Clinical Advancement Center in San Antonio, Texas, led by Dr. Pablo Pergola, is now ready to enroll patients in the 16-week open-label study. The trial will evaluate VAR 200’s efficacy and safety when added to patients’ existing medication regimens. While InvestingPro analysis indicates the company maintains a positive cash-to-debt ratio, its current ratio of 0.18 suggests potential challenges in meeting short-term obligations.
VAR 200 is designed to address renal lipotoxicity, a condition where excess cholesterol and lipids accumulate in the kidneys’ filtration system, causing protein leakage into urine and disease progression. The drug is administered intravenously twice weekly.
"Despite newer treatment options for kidney disease, over 130,000 patients progress to renal failure each year in the US," said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President, according to the company’s press release.
The primary efficacy endpoint is the percent change in urinary albumin to creatinine ratio from baseline to week 12. Preliminary data is expected in the second half of 2025, with final results anticipated in the second half of 2026.
In preclinical studies, VAR 200 demonstrated reduced levels of cholesterol and lipids, protection against renal injury and fibrosis, and improvement in proteinuria across three types of kidney disease models.
The company states that this Phase 2a study will provide the first proof-of-concept in patients with kidney disease for VAR 200, which is also being developed for focal segmental glomerulosclerosis (FSGS) and potentially Alport Syndrome. For investors tracking clinical-stage biotech companies, InvestingPro offers 9 additional key insights and detailed financial metrics to evaluate investment potential in emerging pharmaceutical companies.
In other recent news, ZyVersa Therapeutics has entered into a $10 million share purchase agreement with Williamsburg Venture Holdings, allowing the company to sell common stock over a 24-month period. This funding aims to advance the clinical development of ZyVersa’s Cholesterol Efflux Mediator VAR 200, which targets chronic kidney diseases. Additionally, the company is initiating a Phase 2a trial for VAR 200 in Diabetic Kidney Disease patients, with insights expected to inform further trials in Focal Segmental Glomerulosclerosis (FSGS). ZyVersa has also announced promising study results for its Inflammasome ASC Inhibitor IC 100 as a potential therapy for Parkinson’s Disease, with preparations underway for proof-of-concept studies in animal models. Furthermore, ZyVersa is developing IC 100 as a complementary therapy for obesity-related cardiometabolic issues and plans to start a preclinical study in 2025. The company has formed a Scientific Advisory Board to guide the clinical development of IC 100, which is designed to mitigate inflammation by targeting multiple inflammasomes. These developments are part of ZyVersa’s broader strategy to address unmet medical needs in inflammatory and renal diseases.
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