ZyVersa Therapeutics Highlights Data on Kidney Lipotoxicity in Diabetic Kidney Disease
Breakthrough Clinical Results
ZyVersa Therapeutics announced data highlighting the critical need for therapies targeting kidney lipotoxicity in diabetic kidney disease (DKD). The company is developing VAR 200, a Cholesterol Efflux Mediator™, to remove excess lipids from the kidneys. A Phase 2a clinical trial in DKD patients has begun, with initial data expected in the second half of the year. Future studies are planned for patients with other kidney diseases like focal segmental glomerulosclerosis (FSGS) and Alport syndrome. The global market for kidney disease treatments is substantial, projected to reach $30 billion by 2034.
Key Highlights
- Data demonstrates a critical need for therapies targeting kidney lipotoxicity in DKD.
- ZyVersa's VAR 200, a Cholesterol Efflux Mediator™, is designed to remove excess lipids from kidneys.
- Phase 2a clinical trial in DKD patients is underway, with initial data expected in the second half of 2025.
- Future studies planned for patients with FSGS and Alport syndrome.
Incidence and Prevalence
Global Estimates of Diabetic Kidney Disease Incidence and Prevalence
Global Incidence
In 2021, global chronic kidney disease related to Type 2 diabetes mellitus (CKD-T2DM) reached 2.01 million incidence cases, representing a 150.92% increase since 1992. Population growth and aging contributed to 80% of this substantial rise.
The age-standardized incidence rate (ASIR) varies significantly by region, ranging from 15.09 per 100,000 in low sociodemographic index (SDI) regions to 23.07 in high SDI regions. Notably, 175 countries showed an increasing ASIR trend.
China, India, the United States, and Japan account for 69% of global incidence cases. Unfavorable trends in ASIR increase were generally found in most high-middle and middle SDI countries, such as China (net drift=0.15% per year) and Mexico (net drift=1.17% per year).
Global Prevalence
Diabetic nephropathy affects approximately one-third of people with type 1 or type 2 diabetes mellitus. The prevalence of diabetic kidney disease (defined as estimated glomerular filtration rate less than 60 ml/min/1.73 m² and/or microalbuminuria among adults with diabetes) has plateaued since the early to mid-2000s at approximately 26-27%.
Regional prevalence data shows significant variation: - In sub-Saharan African countries, a 2018 meta-analysis revealed a pooled overall prevalence of 35.3% (95% CI 27.46-43.14) - In type-2 diabetes mellitus specifically, the prevalence was 41.4% (95% CI 32.2-50.58%) - In Eastern Africa, prevalence was 29.7% (95% CI 14.3-45.1%) - A 2017 study from Saudi Arabia found an overall prevalence of 10.8% - In Ethiopia, the estimated pooled prevalence of CKD among DM patients was 18% (95% CI 14.0, 22.0) - In Taiwan, prevalence increased from 13.32% in 2000 to 15.42% in 2009
Risk Factors and Trends
Age-period-cohort analyses indicated a high incidence risk near age 80, with worsening risks for recent periods and birth cohorts, except in high SDI areas. The overall prevalence of estimated glomerular filtration rate less than 60 ml/min/1.73 m² increased from 4.8% in 1988-1994 to 6.9% in 2003-2004, but has since stabilized at 6.4-6.9% up to 2011-2012.
There is a continued rise in CKD and diabetic kidney disease prevalence among blacks and Mexican-Americans in the last decade. A similar pattern of stable prevalence of CKD since the early 2000s is seen in England, Norway, and Korea.
Risk factors consistently identified across studies include diabetes duration, retinopathy, neuropathy, hypertension, age >45 years, hyperlipidemia, male gender, smoking, and poor glycemic control. In Ethiopia, significant risk factors include age ≥60 years (OR = 3.07), rural residence (OR = 1.40), duration of DM >5 years (OR = 2.47), and proteinuria (OR = 3.30).
As the total number of people with diabetes is projected to increase substantially to 2050, the prevalence of diabetic nephropathy will rise dramatically, producing significant social and economic ramifications, particularly in the developing world.
Economic Burden
Economic Burden of Treating Diabetic Kidney Disease in USA and Europe
United States
- The total annual medical costs for managing diabetic nephropathy in the USA were US dollars 16.8 billion (range: US dollars 8.5-25.2 billion)
- This includes US dollars 1.9 billion for Type 1 diabetes and US dollars 15.0 billion for Type 2 diabetes
- The total cost per person with diabetic nephropathy and/or kidney transplant is US dollars 3735
- Kidney replacement therapy accounts for 2-3% of total healthcare expenditure in developed countries
- For CKD/ESRD patients requiring catheter-directed interventions, the median total cost was $32,935
- The most recent estimate (2022) shows dapagliflozin added to standard care for diabetic nephropathy had a lifetime cost of $110,689.25 compared to standard care alone at $106,150.25
- Dapagliflozin demonstrated an incremental cost-effectiveness ratio (ICER) of $21,141.51 per additional quality-adjusted life-year (QALY)
- Dapagliflozin yielded a lifetime QALY of 2.8 compared to 2.6 QALYs for standard care alone
Europe/UK
- In the UK, the total annual costs to the NHS of managing diabetic nephropathy were US dollars 1.2 billion (£765 million)
- This includes US dollars 231 million for Type 1 diabetes and US dollars 933 million for Type 2 diabetes
- The total cost per person with diabetic nephropathy in the UK is US dollars 2672 (£1758), which is 40% lower than in the USA
- A 2024 European study found yearly costs for CKD were 4478€ ± 9804€, rising to 6683€ ± 10,953€ for subjects with eGFR < 30
- Costs increased significantly with disease severity, gender and age
- Hospitalization, medications, and specialist visits were identified as the main cost items
- A 2005 UK study showed that irbesartan treatment led to cost savings of £5125 and £2919 per patient compared to amlodipine and control
- Irbesartan improved projected discounted life expectancy by 0.07 and 0.21 years over 10 years versus amlodipine and control
- Across European countries, irbesartan treatment was cost-saving with benefits evident after 2-3 years of treatment
General Economic Impact
- The economic impact extends to indirect societal costs such as productivity loss by patients and caregivers
- Primary prevention, early screening, and home-based dialysis therapy should be implemented for cost-containment
- Kidney transplant provides better outcomes than dialysis and is cost-effective in long run
- Multimorbidity and functional disability negatively impact prognosis and care costs
- Preservation of functional capacity and adequate management of comorbidities may help decrease healthcare resource consumption, especially in older patients
Drug used in other indications
VAR 200 Clinical Trials Beyond Diabetic Kidney Disease
I don't have specific information about VAR 200 clinical trials for indications other than Diabetic Kidney Disease. The available data doesn't detail any additional indications being investigated, nor does it provide information about intervention models, dosing regimens, or administration methods for VAR 200 trials.
Without confirmed clinical trial data, I cannot provide details about:
- Additional disease indications beyond Diabetic Kidney Disease
- Intervention protocols used in these trials
- Dosing regimens for different indications
- Administration methods being tested
- Clinical trial phases (I, II, III, or IV) for non-Diabetic Kidney Disease indications
For the most current and accurate information about VAR 200 clinical trials, I recommend consulting official clinical trial registries such as ClinicalTrials.gov, pharmaceutical company announcements, or recent medical literature focusing on 2-hydroxypropyl-beta-cyclodextrin research.
