| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 9, 2025 5:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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Initiation of patient recruitment marks a key milestone in the development of VAR 200, a potential first-in-class treatment for kidney disease addressing renal lipotoxicity.There are no available drugs targeting renal lipotoxicity that damages the kidneys' filtration system, causing protein leakage into the urine (proteinuria) and disease progression.VAR 200, designed to alleviate renal lipid accumulation, has preclinical data in three types of kidney disease (DKD, Focal Segmental Glomerulosclerosis, Alport Syndrome) demonstrating reduced levels of cholesterol and lipids, protection against renal injury and fibrosis, and improvement in proteinuria.This Phase 2a study will provide the first p
KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases.Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — bot
WESTON, Fla., May 07, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA), a clinical-stage biopharmaceutical company specializing in first-in-class therapies for inflammatory and renal diseases, announces significant developments for Inflammasome ASC Inhibitor IC 100. CEO Stephen C. Glover issued a shareholder letter detailing the company's strategy to position IC 100 as a complementary therapy to GLP-1 agonists to treat obesity-associated cardiometabolic complications. Obesity: A Global Health Crisis with Unmet Medical Needs Obesity has reached pandemic proportions, affecting over 40% of Americans, with a projected increase to 51% of the global population within 12 years
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
S-1 - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
KEY HIGHLIGHTS First patient expected to start therapy by end of Q2-2025 in Phase 2a proof-of concept clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD).Obesity-associated cardiometabolic preclinical proof-of-concept study with Inflammasome ASC Inhibitor IC 100 planned to begin by end of Q2-2025.Investigational New Drug Application (IND) for IC 100 anticipated to be submitted H2-2025, followed by initiation of a Phase 1 clinical trial in healthy overweight subjects at risk of cardiometabolic diseases.Groundbreaking data demonstrating IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation — bot
KEY HIGHLIGHTS: Phase 2a proof-of concept clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease (DKD) expected to begin H1-2025. Regulatory path for VAR 200's lead indication, focal segmental glomerulosclerosis (FSGS), expected to be shorter based on FDA's alignment with data supporting proteinuria reduction as a clinical trial endpoint for approval of FSGS drugs (Parasol Initiative). Obesity proof-of-concept studies with Inflammasome ASC Inhibitor IC 100 in diet-induced obesity (DIO) mouse models are planned to begin H1-2025.Investigational New Drug Application (IND) for IC 100 is anticipated to be submitted H2-2025, followed by initiation
KEY BUSINESS HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease expected to begin Q1-2025.New Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board (SAB) was formed in October 2024 to support development of Inflammasome ASC Inhibitor IC 100 for obesity with metabolic complications.Two obesity proof-of-concept studies with IC 100 in diet-induced obesity (DIO) mouse models are planned, which will include assessment of various metabolic parameters. At least one of the studies is targeted to begin Q4-2024.IC 100 Investigational New Drug (IND) submission is planned for Q2-2025, and once cleared, will be followed by
SC 13G/A - ZyVersa Therapeutics, Inc. (0001859007) (Subject)