| 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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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
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 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)
10-Q - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
DEFA14A - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
DEF 14A - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)