ZyVersa Therapeutics Highlights Data Demonstrating a Critical Need for Therapies to Address Kidney Lipotoxicity to Alleviate Diabetic Kidney Disease (DKD) and Its Progression
ZyVersa Therapeutics (Nasdaq: ZVSA) highlights critical data demonstrating the role of lipotoxicity in diabetic kidney disease (DKD) progression. The company is developing Cholesterol Efflux Mediator鈩� VAR 200, a first-in-class drug targeting kidney lipotoxicity, with a Phase 2a trial in DKD patients actively screening for enrollment.
Research shows that diabetes-related metabolic issues cause kidney lipid accumulation, leading to inflammation and fibrosis that promote disease progression. The company plans future studies for rare kidney diseases, including focal segmental glomerulosclerosis (FSGS) and Alport Syndrome. Notably, the global kidney disease drug market reached $18 Billion in 2024 and is projected to reach $30 Billion by 2034.
ZyVersa Therapeutics (Nasdaq: ZVSA) mette in evidenza dati chiave che dimostrano il ruolo della lipotossicit脿 nella progressione della malattia renale diabetica (DKD). L'azienda sta sviluppando Cholesterol Efflux Mediator鈩� VAR 200, un farmaco di prima classe che mira alla lipotossicit脿 renale; un trial di Fase 2a su pazienti con DKD 猫 attualmente in fase di screening per l'arruolamento.
Le ricerche mostrano che problemi metabolici legati al diabete causano accumulo di lipidi nel rene, provocando infiammazione e fibrosi che favoriscono la progressione della malattia. L'azienda prevede studi futuri per malattie renali rare, tra cui la glomerulosclerosi segmentaria e focale (FSGS) e la sindrome di Alport. In particolare, il mercato globale dei farmaci per le malattie renali ha raggiunto 18 miliardi di dollari nel 2024 ed 猫 previsto che arrivi a 30 miliardi di dollari entro il 2034.
ZyVersa Therapeutics (Nasdaq: ZVSA) destaca datos clave que demuestran el papel de la lipotoxicidad en la progresi贸n de la enfermedad renal diab茅tica (DKD). La compa帽铆a est谩 desarrollando Cholesterol Efflux Mediator鈩� VAR 200, un f谩rmaco de primera clase dirigido a la lipotoxicidad renal; un ensayo de fase 2a en pacientes con DKD est谩 en proceso de selecci贸n para su reclutamiento.
Los estudios indican que alteraciones metab贸licas relacionadas con la diabetes provocan acumulaci贸n de l铆pidos en el ri帽贸n, lo que desencadena inflamaci贸n y fibrosis que aceleran la progresi贸n de la enfermedad. La compa帽铆a planea estudios futuros para enfermedades renales raras, incluidas la glomeruloesclerosis segmentaria y focal (FSGS) y el s铆ndrome de Alport. Cabe destacar que el mercado global de f谩rmacos para enfermedades renales alcanz贸 los $18 mil millones en 2024 y se proyecta que llegue a $30 mil millones para 2034.
ZyVersa Therapeutics (Nasdaq: ZVSA)電� 雼闺嚚靹� 鞁犾灔歆堩櫂(DKD) 歆勴枆鞐愳劀 歆�歆堧弲靹�(lipotoxicity)鞚� 彀頃橂姅 鞐暊鞚� 氤挫棳欤茧姅 頃奠嫭 雿办澊韯半ゼ 臧曥“頄堨姷雼堧嫟. 須岇偓電� 鞁犾灔 歆�歆堧弲靹膘潉 響滌爜鞙茧 頃橂姅 斓滌磮 瓿勳棿鞚� 鞎诫鞚� Cholesterol Efflux Mediator鈩� VAR 200鞚� 臧滊皽 欷戩澊氅�, DKD 頇橃瀽毳� 雽�靸侅溂搿� 頃� 2a靸� 鞛勳儊鞁滍棙鞚� 順勳灛 霌彪 鞁偓毳� 歆勴枆頃橁碃 鞛堨姷雼堧嫟.
鞐瓣惮鞐� 霐半ゴ氅� 雼闺嚚鞕� 甏�霠悳 雽�靷� 鞚挫儊鞚� 鞁犾灔鞐� 歆�歆堨潉 於曥爜頃橁矊 頃滊嫟瓿� 頃橂┌, 鞚措姅 鞐检瓿� 靹湢頇旊ゼ 齑夓頃� 歆堧硲 歆勴枆鞚� 臧�靻嶍檾頃╇媹雼�. 須岇偓電� 甑唽 攵勳爤靹� 靷惮觳搓步頇旍(FSGS)瓿� 鞎岉彫韸� 歃濏泟甑办潉 韽暔頃� 頋穩 鞁犾灔歆堩櫂鞐� 雽�頃� 於旉皜 鞐瓣惮霃� 瓿勴殟頃橁碃 鞛堨姷雼堧嫟. 韸鬼瀳 鞝� 靹戈硠 鞁犾灔 歆堩櫂 旃橂鞝� 鞁滌灔鞚� 2024雲勳棎 氙疙檾 180鞏� 雼煬($18 billion)鞐� 雼枅鞙茧┌ 2034云勋棎电� 氙疙檾 300鞏� 雼煬($30 billion)搿� 靹膘灔頃� 瓴冹溂搿� 鞝勲霅╇媹雼�.
ZyVersa Therapeutics (Nasdaq: ZVSA) met en avant des donn茅es cl茅s d茅montrant le r么le de la lipotoxicit茅 dans la progression de la maladie r茅nale diab茅tique (DKD). La soci茅t茅 d茅veloppe Cholesterol Efflux Mediator鈩� VAR 200, un m茅dicament de premi猫re classe ciblant la lipotoxicit茅 r茅nale ; un essai de phase 2a chez des patients atteints de DKD est actuellement en cours de s茅lection pour le recrutement.
Les recherches montrent que les perturbations m茅taboliques li茅es au diab猫te provoquent une accumulation de lipides dans le rein, entra卯nant inflammation et fibrose qui favorisent la progression de la maladie. La soci茅t茅 pr茅voit des 茅tudes ult茅rieures pour des maladies r茅nales rares, notamment la glom茅ruloscl茅rose segmentaire et focale (FSGS) et le syndrome d'Alport. Il est 脿 noter que le march茅 mondial des m茅dicaments pour les maladies r茅nales a atteint 18 milliards de dollars en 2024 et devrait atteindre 30 milliards de dollars d'ici 2034.
ZyVersa Therapeutics (Nasdaq: ZVSA) hebt wichtige Daten hervor, die die Rolle von Lipotoxizit盲t bei der Progression der diabetischen Nierenerkrankung (DKD) belegen. Das Unternehmen entwickelt Cholesterol Efflux Mediator鈩� VAR 200, ein First-in-Class-Medikament, das die Lipotoxizit盲t in der Niere adressiert; eine Phase-2a-Studie bei DKD-Patienten befindet sich derzeit im Screening zur Einschreibung.
Untersuchungen zeigen, dass diabetesbedingte Stoffwechselst枚rungen zu einer Lipidansammlung in der Niere f眉hren, was Entz眉ndung und Fibrose ausl枚st und so die Krankheitsprogression f枚rdert. Das Unternehmen plant weitere Studien zu seltenen Nierenerkrankungen, darunter fokal-segmentale Glomerulosklerose (FSGS) und das Alport-Syndrom. Bemerkenswert ist, dass der globale Markt f眉r Medikamente gegen Nierenerkrankungen 2024 18 Milliarden US-Dollar erreichte und voraussichtlich bis 2034 auf 30 Milliarden US-Dollar anwachsen wird.
- None.
- No clinical efficacy data available yet for VAR 200
- Currently over 130,000 patients progress to renal failure annually in the US, indicating significant disease burden
- Competition from existing kidney disease treatments in an $18 Billion market
Insights
ZyVersa's VAR 200 targets kidney lipotoxicity in diabetic kidney disease with Phase 2a trial actively enrolling; data expected this year.
This press release highlights a critical mechanism behind diabetic kidney disease (DKD) progression that has been largely underaddressed in current treatment approaches. The focus on lipotoxicity - the accumulation of lipids in kidney cells - represents an important shift in therapeutic strategy for DKD. The summarized research convincingly establishes that diabetes-related metabolic dysfunction leads to abnormal lipid accumulation in kidney cells, particularly podocytes, triggering inflammation and fibrosis that progressively damages kidney function.
What makes ZyVersa's approach noteworthy is that VAR 200 directly targets the impaired cholesterol efflux pathway, which the cited literature identifies as a key driver in DKD pathology. The dual mechanism - direct removal of lipids and upregulation of cholesterol transporters ABCA1 and ABCG1 - addresses both immediate lipid overload and the compromised natural removal system in kidney cells.
The initiation of patient screening for their Phase 2a trial marks a significant advancement, with first patient dosing expected this quarter and preliminary data anticipated in H2 2025. If successful, this could represent a first-in-class therapy specifically targeting kidney lipotoxicity, which is currently unaddressed by existing medications. The planned expansion to rare kidney diseases like FSGS and Alport Syndrome also suggests broader applications beyond DKD.
The substantial market opportunity (
- Data show that diabetes-associated metabolic issues lead to kidney lipid accumulation, resulting in inflammation and fibrosis that cause progressive kidney damage and disease progression.
- Earlier data by Kanbay et al (Eur J Clin Invest. 2022) demonstrate that fatty kidney is an independent risk factor for chronic kidney disease (CKD), not just DKD, and reinforce that lipid accumulation promotes release of pro-inflammatory cytokines leading to inflammation, fibrosis, and CKD progression.
- ZyVersa is developing Cholesterol Efflux Mediator鈩⒙燰AR 200 to mediate removal of damaging excess lipids from the kidneys鈥� filtration system. VAR 200 directly removes cholesterol and lipids from kidney cells, and it upregulates cholesterol transporters, ABCA1 and ABCG1 for active removal.
- A phase 2a clinical trial in patients with DKD has been initiated and is actively screening patients for enrollment. Future studies are planned for patients with rare kidney diseases, focal segmental glomerulosclerosis (FSGS), VAR 200鈥檚 lead indication, and Alport Syndrome.
- The global drug market for kidney diseases was
$18 Billion in 2024, with$30 Billion projected by 2034 (Precedence Research).
WESTON, Fla., Aug. 14, 2025 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; 鈥淶yVersa鈥�), 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, highlights key data on the role of lipotoxicity in the development and progression of DKD from a review article, , recently published in Frontiers in Immunology. This article, which summarized 172 papers, demonstrated that under diabetic conditions, kidney cells undergo significant lipid metabolic abnormalities resulting in accumulation of lipids that trigger inflammation and fibrosis leading to DKD progression.
鈥淭his large body of evidence from 2 review papers demonstrates the critical need for therapies to treat kidney lipotoxicity, a crucial factor in the pathology of DKD and other kidney diseases, such as FSGS and Alport syndrome,鈥� commented Stephen C. Glover, ZyVersa鈥檚 Co-founder, Chairman, CEO, and President. 鈥淐urrently, over 130,000 patients with kidney disease 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 are hopeful that by alleviating lipotoxicity with Cholesterol Efflux Mediator鈩⒙燰AR 200, kidney injury and disease progression will be reduced, lowering these statistics and improving patients鈥� quality of life. The first patient in our VAR 200 Phase 2a trial in patients with DKD is expected to start therapy by end of this quarter, with an initial data read-out in the second half of the year.鈥�
Overview of Key Findings
Metabolic issues associated with diabetes, especially insulin resistance and high blood glucose, lead to abnormal lipid metabolism resulting in kidney lipid accumulation, inflammation, and fibrosis.
Multiple impaired pathways contribute to lipid accumulation:
- Insulin resistance increases release of free fatty acids and uptake by kidney cells
- Activation of fatty acid synthesis pathways leads to excessive lipid production
- Impaired cholesterol efflux (removal) resulting from reduced function of cholesterol transporters, ABCA1 and ABCG1, leads to cholesterol and lipid accumulation
- Impaired fatty acid oxidation, reduces ability to break down and use stored lipids
Of the above pathways, impaired cholesterol efflux is a key factor in DKD pathology. It exacerbates lipid accumulation, especially in podocytes, the key component of the kidney鈥檚 filtration system, causing structural damage and impaired filtration resulting in protein leaking into the urine, DKD progression, and ultimately kidney failure, if the lipotoxicity is not addressed.
Lipid overload can trigger an inflammasome-induced inflammatory response in kidney cells. Free fatty acids activate inflammasomes initiating an inflammatory cascade via release of IL-1尾. Inflammasome activation also induces upregulation of lipid synthesis-related genes while inhibiting expression of lipid efflux transporters like ABCA1, further increasing lipid accumulation. This creates a vicious cycle, causing continuous decline in renal function and ultimately causes irreversible damage.
Currently, no drugs specifically target kidney lipotoxicity.
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 鈥� Cholesterol Efflux Mediator鈩� 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 www.zyversa.com.
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鈥檚 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. (鈥淶yVersa鈥�) uses words such as 鈥渁nticipates,鈥� 鈥渂elieves,鈥� 鈥減lans,鈥� 鈥渆xpects,鈥� 鈥減rojects,鈥� 鈥渇uture,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渃ould,鈥� 鈥渆stimates,鈥� 鈥減redicts,鈥� 鈥減otential,鈥� 鈥渃ontinue,鈥� 鈥済uidance,鈥� 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鈥檚 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鈥檚 plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa鈥檚 planned preclinical and clinical trials; the timing of the availability of data from ZyVersa鈥檚 preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa鈥檚 plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa鈥檚 product candidates; ZyVersa鈥檚 commercialization, marketing and manufacturing capabilities and strategy; ZyVersa鈥檚 ability to protect its intellectual property position; and ZyVersa鈥檚 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.
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FAQ
What is ZyVersa's VAR 200 drug candidate and how does it work?
When will ZVSA report initial data from the VAR 200 Phase 2a trial?
What is the market size for kidney disease treatments that ZVSA is targeting?
What kidney diseases is ZyVersa targeting with VAR 200?
How does lipotoxicity affect kidney disease progression?
