Drugs

ZyVersa Touts Approval Path for Kidney Disorder Drug

ZyVersa Therapeutics says it is optimistic about a new regulatory development that could significantly shorten the path to approval for treatments targeting focal segmental glomerulosclerosis (FSGS), a rare and debilitating kidney disorder. FSGS affects about 40,000 people in the U.S. and is one of the leading causes of kidney failure, often requiring multiple transplants during a patient’s lifetime, it says. Until now, high regulatory hurdles have made drug development for FSGS particularly difficult, with trials typically requiring long-term follow-up in large patient populations — an unrealistic expectation for rare diseases, according to the company.

In a 4/8 shareholder letter, ZyVersa highlighted recent recommendations from the PARASOL initiative, a collaboration between FDA and rare kidney disease experts, including what it calls a game changer — a reduction in proteinuria (protein in the urine) over a 24-month period can now serve as a surrogate endpoint for full FDA approval. This change could allow for shorter and more efficient clinical trials with smaller patient groups, the company says.

ZyVersa says the use of the surrogate endpoint would “de-risk” development of ZyVersa’s lead kidney drug candidate, VAR 200, a proprietary cholesterol efflux mediator for treating a range of chronic kidney diseases, with FSGS as the initial focus. Expansion into conditions like Alport Syndrome and Diabetic Kidney Disease (DKD) is also planned.

ZyVersa is set to launch a Phase 2a proof-of-concept trial of VAR 200 in DKD patients during the first half of 2025. Results from this trial are expected to inform and optimize the design of a subsequent FSGS trial.

Additionally, the company believes the regulatory shift could also boost the prospects of Travere Therapeutics’ Filspari (sparsentan), which previously failed to gain FDA approval due to reliance on eGFR markers rather than a proven reduction in kidney failure. With the new surrogate endpoint, Travere recently filed a supplemental NDA seeking traditional approval. ZyVersa notes that VAR 200, which targets cholesterol accumulation in the kidney’s filtration system, is designed to work alongside Filspari and other standard therapies.

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