ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA) stock was trading higher on Tuesday, with a session volume of 160.9 million compared to the average volume of 4.03 million as per data from Benzinga Pro.

What Happened

ZyVersa Therapeutics provided regulatory and product support for FDA-authorized Emergency Compassionate Use of Cholesterol Efflux Mediator VAR 200 in a patient with ApoCII amyloidosis.

Emergency Compassionate Use, also known as Emergency Expanded Access, is a pathway that allows patients with severe or immediately life-threatening diseases or conditions to access an investigational drug for treatment outside of clinical trials.

VAR 200 treatment and monitoring will follow the protocol of the ongoing Diabetic Kidney Disease (DKD) clinical trial, VAR200-0301.

Also Read: FDA Raises Manufacturing Concerns, Delays Unicycive’s Kidney Disease Drug Approval

Why It Matters

“We look forward to learning the effects of VAR 200 on proteinuria in this patient with ApoCII amyloidosis, which in combination with the data from our Phase 2a DKD trial, will support the design of our ongoing VAR 200 clinical development program,” said Stephen Glover, ZyVersa’s co-founder, chairman, CEO and president.

Cholesterol Efflux Mediator VAR 200 (2-hydroxypropyl-β-cyclodextrin, 2HPβCD) is an injectable drug in Phase 2 development to ameliorate renal lipid accumulation, which damages the kidneys’ filtration system and contributes to the development and progression of kidney disease.

VAR 200 removes excess lipids from the kidney both passively and actively by upregulating cholesterol efflux transporters ABCA1 and ABCG.

Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate reduced levels of cholesterol and lipids, protection against renal injury and fibrosis, and improvement in proteinuria.

The lead indication for VAR 200 is orphan kidney disease, focal segmental glomerulosclerosis (FSGS).

Before initiating the Phase 2a trial in patients with FSGS, the company is conducting a small Phase 2a trial in patients with diabetic kidney disease, which is expected to provide proof-of-concept for patients more quickly than an FSGS study.

Based on the indication expansion strategy, the company may pursue indications for Alport Syndrome and diabetic kidney disease.

On Tuesday, ZyVersa entered into a warrant inducement agreement with a single institutional investor to immediately exercise Series A-2 and Series A-3 warrants at a reduced exercise price of $0.67, with gross proceeds of $2 million.

Price Action: ZVSA stock was up 56% at $1.03 at the last check on Tuesday.

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