Latest news with #ZyVersa
Associated Press
a day ago
- Business
- Associated Press
ZyVersa Therapeutics Announces First Clinical Site Activation, Initiating Patient Recruitment for Cholesterol Efflux Mediator™ VAR 200's Phase 2a Clinical Trial in Patients with Diabetic Kidney Disease (DKD)
WESTON, Fla., June 26, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; 'ZyVersa'), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that the Clinical Advancement Center, PLLC in San Antonio, Texas is the first clinical site activated and ready for patient recruitment in our VAR 200 Phase 2a clinical study in patients with DKD. The lead investigator is Pablo Pergola, MD, PhD. 'We are pleased to work with Dr. Pergola and his research colleagues at the Clinical Advancement Center to kick off our first-in-human VAR 200 Phase 2a trial in patients with DKD. We share a similar vision to that of Dr. Pergola and the Clinical Advancement Center – to develop innovative treatments that will change the course of kidney disease and improve patients' quality of life,' said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. 'It is this vision that led us to develop a drug, VAR 200, that targets a neglected pathogenic pathway in kidney disease – excess accumulation of cholesterol and lipids in the glomerulus, the main filtering unit of the kidney. There is a large body of evidence demonstrating the critical need for therapies to address kidney lipotoxicity, a key pathway in development and progression of DKD and other kidney diseases. Despite newer treatment options for kidney disease, over 130,000 patients progress to renal failure each year in the US, and more than 800,000 patients are living with renal failure requiring dialysis or transplant to sustain life. We believe that adding VAR 200 to standard-of-care drugs, like ACEs, ARBs, and SGLT2 inhibitors that address other pathogenic pathways, will be disease-modifying and better protect against further kidney injury and disease progression. We look forward to seeing the results of this Phase 2a trial, and to progressing VAR 200 to commercialization.' VAR 200's proof-of-concept Phase 2a study will be conducted at one to two US sites and will enroll an adequate number of subjects to complete eight. It is a 16-week open-label study (12 weeks of treatment and a four-week follow-up period) to evaluate the drug's efficacy and safety in patients with type 2 diabetes and diabetic kidney disease with proteinuria. VAR 200 will be administered intravenously twice weekly at a single dose and will be added to the stable drug regimen used by each patient. The primary efficacy endpoint is percent change from baseline to week 12 in urinary albumin to creatinine ratio. Further details can be found at ABOUT CHOLESTEROL EFFLUX MEDIATOR™ VAR 200 Cholesterol Efflux Mediator™ VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is an injectable drug in phase 2 development to ameliorate renal lipid accumulation that damages the kidneys' filtration system, leading to development and progression of kidney disease. VAR 200 removes excess lipids from the kidney both passively, and actively by upregulation of cholesterol efflux transporters, ABCA1 and ABCG. Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate reduced levels of cholesterol and lipids, protection against renal injury and fibrosis, and improvement in proteinuria. Additional information can be found in the VAR 200 White Paper. The lead indication for VAR 200 is orphan kidney disease, focal segmental glomerulosclerosis (FSGS). Prior to initiating a Phase 2a trial in patients with FSGS, we are conducting a small Phase 2a trial in patients with diabetic kidney disease, which we expect will provide patient proof-of-concept more quickly than an FSGS study. Alport Syndrome and diabetic kidney disease indications may be pursued based on our indication expansion strategy. ABOUT ZYVERSA THERAPEUTICS, INC. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. ('ZyVersa') uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, IR, and Media Contact Karen Cashmere Chief Commercial Officer [email protected] 786-251-9641
Associated Press
29-04-2025
- Health
- Associated Press
ZyVersa Therapeutics Announces Published Data Showing Inflammasome ASC Inhibitor IC 100 Decreases Microglial Inflammasome Activation and Alpha-Synuclein That Contribute to Neurodegeneration in Parkinson's Disease
WESTON, Fla., April 29, 2025 (GLOBE NEWSWIRE) -- 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 newly published data supporting the potential of its Inflammasome ASC Inhibitor IC 100 to slow the progression of Parkinson's disease. Published in npj Parkinson's Disease, a peer-reviewed journal from Nature, the study presents groundbreaking findings from researchers at the University of Miami Miller School of Medicine. The research demonstrates that IC 100 blocks microglial inflammasome activation and reduces neurotoxic alpha-synuclein accumulation—both key contributors to PD progression. 'These are the first data to link ASC speck assembly, NLRP1 inflammasome activation, and alpha-synuclein aggregation in neurons of Parkinson's disease patients,' said Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO and President. 'IC 100, which unlike NLRP3 inhibitors, targets ASC, ASC specks, and multiple types of inflammasomes, blocked microglial NLRP1 inflammasome activation and reduced alpha-synuclein accumulation. These results strengthen our belief in IC 100 as a potential disease-modifying therapy for Parkinson's, and we're preparing to initiate proof-of-concept studies in animal models later this year.' Study Highlights 'Our findings demonstrate that targeting inflammasomes and ASC specks may be a promising approach not only for PD but also for Lewy body dementia (LBD) and Alzheimer's Disease,' said Dr. Robert W. Keane, Professor of Physiology and Biophysics, Neurological Surgery, and Microbiology & Immunology at the University of Miami, and lead author of the study. 'IC 100's mechanism, which uniquely inhibits both ASC speck activity and misfolded protein aggregates, makes it a strong candidate for treating neurodegenerative diseases.' About Inflammasome ASC Inhibitor IC 100 IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity with certain metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here. About ZyVersa Therapeutics, Inc. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a 'pipeline within a product,' with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc ('ZyVersa') uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, Media, and IR Contact: Karen Cashmere Chief Commercial Officer
Associated Press
08-04-2025
- Business
- Associated Press
ZyVersa Therapeutics CEO Issues Shareholder Letter on PARASOL Recommendations Expected to Reduce Drug Development Barrier for Rare Kidney Disease, Focal Segmental Glomerulosclerosis (FSGS)
WESTON, Fla., April 08, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; 'ZyVersa'), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Shareholder Letter addressing the recent PARASOL recommendations expected to shorten drug development time and approval for rare kidney disease, FSGS. The full text of the letter follows. A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER ZyVersa is developing Cholesterol Efflux Mediator™ VAR 200 for treatment of chronic kidney diseases, initially focusing on FSGS as the lead. Plans for indication expansion include treatments for Alport Syndrome and Diabetic Kidney Disease. The global drug market for kidney diseases was $18 Billion in 2024, with $30 Billion projected by 2034 (Precedence Research). Today, I am thrilled to update you on a recent advancement that is expected to be a giant step forward in FSGS drug development and anticipated to derisk development of VAR 200 for its lead indication, FSGS. Prior to conducting Phase 2 clinical trials in FSGS, we are initiating a small Phase 2a proof-of-concept trial with VAR 200 in the first half of this year in patients with DKD. The intent of the study is to quickly obtain first in human renal data prior to initiating a larger phase 2a/b trial in patients with FSGS. The DKD data will also provide insights to help optimize protocol design for the subsequent FSGS study. FSGS is a devastating, progressive, and complex rare kidney disorder affecting around 40,000 people in the US. It is a leading cause of kidney failure, requiring dialysis and transplant for survival. With FSGS, it is common for patients to need more than one kidney transplant since the disease can affect the new kidney in a relatively short period of time. FSGS has an overwhelming negative impact on daily living and quality of life. Disease symptoms, such as fatigue and chronic severe swelling, and the number of required drugs and their side effects interfere with daily activities. It is common for patients to miss a large percentage of school or work days making it challenging to graduate or hold a job. Likewise, patients, especially children, are often hospitalized missing holidays and family celebrations, including their own birthdays. Additionally, patients with FSGS experience a substantial degree of anxiety and emotional impact from fear of needing dialysis or transplant, and from concern about exposure to infectious diseases resulting from the immunosuppressive drugs they are on. This leads to social isolation and loneliness. Kidney failure not only affects patients' quality of life but has a high economic burden. In 2023, an estimated $28 billion was spent on dialysis care and $3.4 billion on transplant patient care. To date, there are no approved drug therapies that effectively prevent or delay FSGS progression to kidney failure. One reason for the lack of drug treatments is the high regulatory hurdle requiring drug developers to demonstrate a substantially reduced FSGS progression to kidney failure. FSGS trials can require decades of follow-up in large study populations to measure kidney failure. This is generally not feasible in clinical trials, especially for rare kidney diseases. Thanks to the initiative of a multi-stakeholder group of rare kidney disease experts and the FDA to identify a robust surrogate endpoint to replace long-term kidney failure outcomes (the PARASOL initiative), it is expected that shorter clinical trials with fewer patients will be required to demonstrate FSGS drug efficacy. The Parasol group recommended a reduction in proteinuria (spillage of protein into the urine) over 24 months as a surrogate endpoint for full regulatory approval of FSGS drugs. According to Dr. Aliza Thompson, PARASOL's Co-chair and Director of the Cardio-Renal Division at the FDA, 'Data supporting the recommendation came from over 25 studies conducted all over the globe and involved more than 1,600 patients, providing a robust foundation for informed regulatory decisions.' Travere is likely to be the first company to benefit from the PARASOL group's recommendations. Despite a 50% reduction in proteinuria, FDA previously denied accelerated approval for Filspari (sparsentan) for FSGS because the drug failed to demonstrate a reduced progression to kidney failure (based on surrogate marker eGFR). The recent PARASOL recommendations are expected to pave the way for FSGS approval for Filspari. Following a promising Type C meeting with the FDA in February, Travere filed a supplemental New Drug Application (sNDA) on March 17, 2025, seeking priority review for traditional approval of FILSPARI® for treatment of FSGS. FDA approval is anticipated in the third quarter of this year, with launch by year's end. In an April 3, 2025 analyst update on Travere, Guggenheim indicated that they believe investors underappreciate the FSGS commercial opportunity, which is substantially larger than that for IgAN. This is based on a higher unmet need for effective FSGS drug therapies since patients progress to kidney failure at twice the rate as IgAN patients, and there are fewer expected competitors reducing price sensitivity. Guggenheim has projected $2 Billion in peak sales for Filspari in FSGS. We are excited about the potential approval of Filspari for FSGS based on a reduction in proteinuria, as it will further support proteinuria as the primary endpoint for VAR 200's FSGS clinical trials. Because VAR 200 targets a unique pathway leading to development and progression of FSGS and other kidney diseases (accumulation of cholesterol and lipids in the kidney's filtration system), VAR 200 will be used as add on therapy to Filspari and other standard of care drugs such as steroids and calcineurin inhibitors. For more information about Cholesterol Efflux Mediator™ VAR 200, Click Here. We thank you for your continued support. Sincerely, Stephen C. Glover Co-Founder, Chairman, Chief Executive Officer, and President ZyVersa Therapeutics ABOUT ZYVERSA THERAPEUTICS, INC. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. For more information, please visit CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc. ('ZyVersa') uses words such as 'anticipates,' 'believes,' 'plans,' 'expects,' 'projects,' 'future,' 'intends,' 'may,' 'will,' 'should,' 'could,' 'estimates,' 'predicts,' 'potential,' 'continue,' 'guidance,' and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Karen Cashmere 786-251-9641
