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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 (NASDAQ: ZVSA) has published new data showing their Inflammasome ASC Inhibitor IC 100 protects against stroke-related cardiovascular injury in preclinical trials. The study, conducted on mice and zebrafish hearts, demonstrated that IC 100 blocked AIM2 inflammasome activation and cell death in the heart, improving cardiac function post-stroke. Key findings showed that IC 100 significantly reduced inflammasome proteins and cardiac inflammation when administered 30 minutes post-stroke. The company plans to progress IC 100's development into phase 1 around mid-2025, targeting obesity-related cardiovascular diseases, which have seen deaths triple between 1999 and 2020.
ZyVersa Therapeutics (ZVSA) reported Q3 2024 financial results and business updates. The company plans to begin Phase 2a clinical trial for VAR 200 in diabetic kidney disease in Q1-2025. Two obesity proof-of-concept studies with IC 100 are planned, with at least one starting in Q4-2024. The company formed a new Obesity, Metabolic & Inflammatory Disease Scientific Advisory Board in October 2024.
Q3 2024 net losses were $2.4 million, improving 17.3% from Q3 2023. R&D expenses decreased 35.3% to $0.4 million, while G&A expenses decreased 17.7% to $1.8 million. The company raised approximately $3.9 million since Q3-2024 and will need additional financing to support operations.
ZyVersa Therapeutics (Nasdaq: ZVSA) highlights published data showing the potential of inflammasome inhibition to protect pancreatic islet beta cells and prevent progression from obesity to type 2 diabetes. Research demonstrated that inflammasome-driven inflammation severely damages pancreatic islets, leading to cell loss and metabolic dysfunction. The study showed that inflammasome NLRP3 inhibition protected pancreatic islet beta cells and improved metabolic status in obesity mouse models. This data supports ZyVersa's development of Inflammasome ASC Inhibitor IC 100 as an add-on to incretin therapy for obesity treatment, with phase 1 trials planned for mid-2025.
ZyVersa Therapeutics highlights a review article supporting the need for drug therapies to treat obesity-related inflammation alongside weight loss drugs. The article, published in Life journal, analyzes 345 publications on inflammasome-induced inflammation in obesity and its comorbidities. Obesity's chronic inflammation increases risks for metabolic diseases, atherosclerosis, tumors, and immune disorders. The company plans to develop Inflammasome ASC Inhibitor IC 100 as an add-on to incretin therapy, targeting multiple inflammasomes including NLRP3 and AIM2. ZyVersa aims to progress IC 100's obesity development program into phase 1 around mid-2025.
ZyVersa Therapeutics (Nasdaq: ZVSA) highlights data published in Aging Cell demonstrating that obesity leads to brain inflammation, potentially increasing the risk of neurodegenerative diseases. The study, conducted on a diet-induced obesity mouse model, showed that:
1. Obesity resulted in significant weight gain and adipose tissue inflammation.
2. Prolonged obesity (26 weeks) in adolescent mice led to systemic inflammation and suppression of neuroprotective factors in multiple brain regions.
3. Mature adult obese mice demonstrated systemic inflammation and reduced neuroprotective factors earlier than younger mice.
ZyVersa's Inflammasome ASC Inhibitor IC 100, which penetrates the brain and key organs affected by obesity, shows potential in controlling CNS and systemic inflammation associated with obesity and its comorbidities, including Parkinson's disease.
ZyVersa Therapeutics (Nasdaq: ZVSA) has announced obesity with metabolic complications as the lead indication for its Inflammasome ASC Inhibitor IC 100. The company's CEO, Stephen C. Glover, highlighted development plans and milestones for the next nine months in a letter to shareholders. IC 100 is anticipated to control chronic systemic inflammation of obesity, attenuate associated metabolic comorbidities, and augment weight loss when added to GLP-1 agonist therapy.
Key milestones include:
- Q4-2024: Initiate IC 100 monotherapy study in DIO mice
- Q1-2025: Start IC 100 combination study with semaglutide in DIO mice
- Q2-2025: File IND
- Q3-2025: Begin IC 100 phase 1 trial in healthy overweight subjects
ZyVersa Therapeutics (Nasdaq: ZVSA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Phase 2a trial for VAR 200 in diabetic kidney disease on track to begin H2-2024.
2. Obesity with metabolic complications selected as lead indication for IC 100.
3. IC 100 IND submission planned for Q4-2024, with Phase 1 trial expected to begin Q1-2025.
4. Net loss of $2.8 million, a 96.5% improvement from Q2 2023.
5. R&D expenses decreased by 41.9% to $0.7 million.
6. G&A expenses decreased by 48% to $2.0 million.
7. Cash position of $0.1 million as of June 30, 2024, sufficient for month-to-month operations.
ZyVersa will need additional financing to support ongoing operations and meet stated milestones.
ZyVersa Therapeutics (Nasdaq: ZVSA) has announced published data supporting the rationale for inhibiting inflammasome ASC with IC 100 to control chronic inflammation. The research, published in EMBO Molecular Medicine, demonstrates that extracellular ASC specks play a important role in the pathogenesis of amyloid A (AA) amyloidosis, a condition characterized by deposition of insoluble amyloid fibrils in tissues and organs.
Key findings include:
- ASC colocalization with SAA in human AA amyloidosis
- ASC specks accelerating SAA fibril formation
- Decreased splenic amyloid load in ASC-lacking mouse models
- Reduced amyloid loads in mice treated with anti-ASCPYD antibodies
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits intra- and extracellular ASC and specks associated with multiple types of inflammasomes, potentially attenuating damaging inflammation in various inflammatory diseases.
ZyVersa Therapeutics (Nasdaq: ZVSA) announces published data showing promise for plasma levels of inflammasome ASC as a biomarker of early cognitive changes in older adults. The study, published in the International Journal of Molecular Sciences, found:
1. Elevated ASC levels in cognitively normal adults who showed decline after one year.
2. Higher ASC levels in those 70+ years old.
3. Excellent ability to differentiate between cognitive decline and normal cognition in 70+ group (AUC 0.81).
This research supports ZyVersa's development of Inflammasome ASC Inhibitor IC 100 for treating neurological and inflammatory diseases. The company aims to address the growing global dementia crisis, expected to affect 114 million people by 2040.
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.
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