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ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA) is a clinical-stage specialty biopharmaceutical company committed to developing first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. Leveraging advanced proprietary technologies, ZyVersa is focused on creating therapeutic solutions that address these critical health challenges.
ZyVersa's impressive pipeline features two main drug development platforms. The Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin) is an injectable drug in clinical development for treating kidney diseases caused by lipid accumulation. Clinical trials for VAR 200 have shown promising results in animal models of diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), and Alport syndrome (AS). The Phase 2a clinical trial protocol for diabetic kidney disease has recently received IRB approval, marking a significant milestone in the drug's development.
The second platform is the Inflammasome ASC Inhibitor IC 100, a novel humanized IgG4 monoclonal antibody. IC 100 inhibits the inflammasome adaptor protein ASC, which plays a crucial role in the body's inflammatory response. The drug is in preclinical development for treating various inflammatory conditions, including neurological diseases like Alzheimer's, multiple sclerosis, and traumatic brain injury. Recent research has highlighted IC 100's potential in addressing obesity-related inflammation and metabolic complications, further expanding its therapeutic scope.
Under the leadership of an experienced team with over 15 years of success in the biopharmaceutical industry, ZyVersa continues to advance its drug candidates towards clinical trials. The company's strategic partnerships and collaborations with notable research institutions like the University of Miami Miller School of Medicine further bolster its research and development efforts.
Financially, ZyVersa is navigating the challenges of a clinical-stage biopharmaceutical company. While the company reported a net loss of $98.3 million for the year ending December 31, 2023, it continues to secure funding through public and private equity, grants, and collaborations. Recent financial updates indicate a net loss improvement for Q1 2024, with operating expenses managed efficiently to support ongoing and future clinical trials.
For more detailed information, visit the ZyVersa Therapeutics website and stay updated with their latest news and developments.
ZyVersa Therapeutics (ZVSA) has chosen obesity and related metabolic complications as the lead indication for its Inflammasome ASC Inhibitor IC 100. This decision is based on the growing global obesity drug market, which reached $24 billion in 2023 and is forecasted to reach up to $131 billion by 2028. Obesity affects over 40% of Americans and is associated with multiple chronic conditions, costing over $1.4 trillion annually in the US.
ZyVersa believes that IC 100, which inhibits multiple types of inflammasomes, could complement GLP-1 agonists by addressing chronic tissue inflammation not targeted by current treatments. The company plans to submit an Investigational New Drug (IND) application in Q4-2024, with Phase 1 clinical trials to follow. Preclinical collaborations are underway to assess IC 100's potential in treating atherosclerosis and obesity-related metabolic syndrome.
ZyVersa Therapeutics (ZVSA) announces publication of research demonstrating that its Inflammasome ASC Inhibitor IC 100 restored retinal structure and function in a Retinopathy of Prematurity (ROP) animal model. The study, published in Angiogenesis, showed that IC 100 suppressed retinal microglia activation, attenuated inflammation, abnormal vascularization, and retinal thinning. Key findings include:
- IC 100 decreased expression of inflammasome-related molecules and inflammatory cytokines
- It reduced ASC speck formation and microglial activation
- Structural and functional improvements correlated with corrections of hyperoxia-modulated gene pathways
This research supports IC 100's potential in treating ROP, a leading cause of childhood blindness worldwide, and adds to its promising indications including early Alzheimer's disease, multiple sclerosis, and acute respiratory distress syndrome.
ZyVersa Therapeutics (Nasdaq: ZVSA) announced that its CEO, Stephen C. Glover, will speak at the H.C. Wainwright 3rd Annual Kidney Conference on July 15, 2024. During his presentation, Glover will discuss the unique mechanism of Cholesterol Efflux Mediator™ VAR 200, which is in Phase 2a development for treating kidney diseases. The conference, held virtually, will also allow participants to schedule one-on-one meetings with Glover. With over 37 million Americans suffering from chronic kidney disease, ZyVersa is advancing its pipeline to address this significant unmet medical need.
ZyVersa Therapeutics (Nasdaq: ZVSA) announced its Q1-2024 financial results and provided a business update. Net losses were $2.8 million, a 20.2% improvement from Q1-2023. The company has $2.0 million in cash, sufficient for month-to-month operations but will need additional financing. Key developments include the initiation of a Phase 2a clinical trial for Cholesterol Efflux MediatorTM VAR 200 in diabetic kidney disease and upcoming GLP toxicology studies for Inflammasome ASC Inhibitor IC 100. Other milestones include preclinical data readouts and collaborations for IC 100, focusing on atherosclerosis and obesity-related conditions. ZyVersa raised $2.7 million through warrant exercises.
ZyVersa Therapeutics announced that CEO Stephen C. Glover will participate in the 2024 BIO International Convention in San Diego from June 3-6, 2024. ZyVersa is developing treatments for renal and inflammatory diseases using two proprietary technologies: the Cholesterol Efflux Mediator™ VAR 200 and the Inflammasome ASC Inhibitor IC 100. The company plans to start a Phase 2a clinical trial for VAR 200 in diabetic kidney disease in the first half of 2024 and is conducting preclinical studies for expanding IC 100's indications to atherosclerosis, obesity, and Parkinson’s disease. An IND filing for IC 100 is expected by year-end, with Phase 1 trials starting in Q1-2025. Glover will be available for one-on-one meetings to discuss these developments.
ZyVersa Therapeutics, Inc. announces a publication highlighting the role of inflammasome-mediated inflammation in Alzheimer's Disease (AD) and its impact on heart health. The company is developing Inflammasome ASC Inhibitor IC 100 to target multiple inflammasomes and reduce inflammation. The research indicates a potential therapeutic target for cardiac comorbidities in AD and beyond.
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