WESTON, Fla. — ZyVersa Therapeutics, Inc., a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD). The clinical trial is expected to begin in the first quarter of 2024.
George Clinical is a leading global CRO, headquartered in Sydney, Australia, with more than 500 experienced people in 39 locations providing the full range of clinical trial services to pharmaceutical, medical device, and diagnostic customers for all trial phases, registration, and post-marketing trials. George Clinical, who combines scientific and clinical leadership with expert trial delivery to create distinctive world-class solutions, was the recipient of Citeline’s 2023 Clinical Research Team of the Year. They were recognized for their success in achieving their goals, effective work practices, creative solutions, and meeting major milestones within expected timelines.
“Initiation of the Phase 2a trial in patients with DKD marks a major milestone in the development of Cholesterol Efflux MediatorTM VAR 200 and for ZyVersa. It is the first clinical trial for VAR 200 and will help establish its effectiveness and safety in renal patients, and it will provide valuable insights to guide development for other planned renal indications (focal segmental glomerulosclerosis and Alport syndrome),” said Stephen C. Glover, ZyVersa’s Co-founder, Chief Executive Officer, and Chairman. “We are pleased to partner with George Clinical to manage this important study. With their unparalleled renal research experience in more than 50 chronic renal disease trials and their reputation as a high performing renal CRO, we are confident that our trial will be conducted in an efficient and timely manner to achieve our milestones and advance VAR 200’s development program to the next level.”
“Collaborating with ZyVersa Therapeutics on this trial shows not only our passion for kidney research but also the commitment to provide the necessary clinical research around innovative treatments that could help patients with unmet medical needs,” said George Clinical Chief Medical Officer Maria Ali.
About VAR 200
Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease and its progression. VAR 200 passively and actively removes excess lipids from the kidney.
Preclinical studies in animal models of diabetic kidney disease, FSGS, and Alport syndrome, demonstrate that removal of excess cholesterol and lipids from the kidney’s filtration system with VAR 200 protects against structural damage and reduces excretion of protein in the urine (proteinuria). VAR 200 has potential to treat multiple kidney diseases, including diabetic kidney disease, and rare kidney diseases, FSGS (focal segmental glomerulosclerosis) and Alport syndrome.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases.
Contacts
Casey McDonald
[email protected]
646-577-8520
Dave Schemelia
[email protected]
609-468-9325