| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | September 9, 2024 5:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "ZyVersa"))))), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100.
Publication showed that IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function. Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.
SC 13G/A - ZyVersa Therapeutics, Inc. (0001859007) (Subject)
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
KEY HIGHLIGHTS Phase 2a clinical trial for Cholesterol Efflux Mediator™ VAR 200 in patients with diabetic kidney disease on track to begin H2-2024.Obesity with related metabolic complications selected as lead indication for Inflammasome ASC Inhibitor IC 100. Supportive data from preclinical study in atherosclerosis, a common obesity-related metabolic complication, is expected to be available H2-2024. IC 100 Investigational New Drug (IND) submission planned for Q4-2024, to be followed by initiation of a Phase 1 clinical trial in obesity with metabolic complications expected to begin Q1-2025.Raised approximately $0.8 million from exercise of investor warrants. WESTON, Fla., Aug. 09, 2024 (
Key Highlights: Second research site selected to enhance enrollment in the Phase 2a clinical trial for Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease planned to begin H1-2024.GLP toxicology studies for Inflammasome ASC Inhibitor IC 100 scheduled to begin H1-2024, with planned Investigational New Drug (IND) submission Q4-2024, and Phase 1 clinical trial initiation Q1-2025.Atherosclerosis preclinical data readout for Inflammasome ASC Inhibitor IC 100 on schedule for H1-2024.Initiation of preclinical study to assess Inflammasome ASC Inhibitor IC 100 for obesity-associated metabolic comorbidities scheduled to begin Q2-2024 with completion expected by year's end.R
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
10-Q - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
Strokes affect 795,000 people annually in the US. Obesity, a top risk factor for strokes, is associated with around one out of five strokes.Cardiac complications following a stroke are a leading cause of mortality and morbidity, second only to acute neurological injury.The pathomechanism underlying cardiac dysfunction following a stroke includes a surge of catecholamines, such as epinephrine, which induces inflammasome activation triggering a systemic inflammatory response.The published data showed that following a stroke, Inflammasome ASC Inhibitor IC 100 blocked AIM2 inflammasome activation and cell death (pyroptosis) in the heart and improved cardiac function.Data from this article suppor
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
During obesity, inflammasome-driven inflammation results in significant loss of pancreatic islet beta cell mass, severely impairing the insulin secreting capacity of the remaining beta cells.Preserving pancreatic islet beta cell function is key to prevention of insulin resistance and development of type 2 diabetes.The published data showed that inflammasome NLRP3 inhibition was protective of pancreatic islet beta cells, restoring their function and improving metabolic status in an obesity DIO mouse model.Data from this article support ZyVersa's development of Inflammasome ASC Inhibitor IC 100 for obesity and its associated comorbidities to be used as an add-on to incretin therapy. WESTON, F