SEC Form 10-K filed by ZyVersa Therapeutics Inc.
$ZVSA
Biotechnology: Pharmaceutical Preparations
Health Care
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10-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
8-K - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
S-8 - ZyVersa Therapeutics, Inc. (0001859007) (Filer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
4 - ZyVersa Therapeutics, Inc. (0001859007) (Issuer)
SC 13G/A - ZyVersa Therapeutics, Inc. (0001859007) (Subject)
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
In obesity-associated cardiomyopathy (OAC), heart muscle is structurally and functionally abnormal, impairing the ability to effectively pump blood. Five-year survival rate is less than 50%, with congestive heart failure and sudden cardiac death predominant causes of death.Data showed that NLRP3 inflammasome inhibition attenuated inflammation, heart muscle enlargement and fibrosis, and improved heart function.Data support the potential of ZyVersa's Inflammasome ASC Inhibitor IC 100 as an effective treatment option for patients with obesity and its associated cardiovascular comorbidities. WESTON, Fla., March 18, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (NASDAQ:ZVSA, or "Zy
Alzheimer's disease (AD), affecting around 6.9 million people in the US, is ranked as the seventh leading cause of death and is the most common cause of dementia among older adults.AD begins with buildup of amyloid beta (Aβ) plaques and neurofibrillary tangles in the brain that causes brain cells to die over time and the brain to shrink.The data demonstrate that initial deposition of Aβ triggers NLRP3 inflammasome activation causing release of ASC specks which rapidly enhance aggregation of Aβ. Aβ aggregates also activate NLRP3 inflammasomes thus triggering an ongoing cycle of IL-1β and ASC-mediated inflammation and Aβ deposition in the brain leading to AD progression. NLRP3 Inflammasome inh
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
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 (