WF10 for treatment of Diabetic Kidney Disease (DKD)
Our phase-II multi-centric clinical trials, initially in Southeast Asia and subsequently in Europe, aim to demonstrate efficiency of WF10 in treatment of advanced Diabetic Kidney Disease (DKD), corresponding to CKD stage 3a-4.
Information about the clinical trial
1. What is WF10?
a) Formulation and application
WF10 represent a sterile isotonic aqueous solution for i.v. infusion. The drug is produced from the drug substance TCDO, a chlorite-peroxide reaction product.
b) Diabetic indications
WF10 is approved in Thailand for multiple indications associated with chronic inflammation, including co-treatment of diabetic foot ulcer (DFU), a severe late-stage diabetic vascular complication. This project wants to re-purpose WF10 for treatment of diabetic kidney disease (DKD), one of the earliest and most common clinical manifestations of diabetic vasculopathy.
2. How does WF10 act?
With its unique and multi-target pharmacological activity, WF10 fills the therapeutic gap between blood sugar control at classical diabetic care and the frequently inevitable development of diabetic vascular complications.
a) Direct immune-modulation
WF10 exhibits direct immune-modulatory and inflammation-resolving properties. Physiological immunological defense mechanisms (immune competence) are maintained/restored.
b) Detoxification of hemolytic products
Hemolytic products (free hemoglobin/heme) emerging from Red Blood Cells (RBCs) are very strong vasotoxins and are dose-dependently detoxified by chlorite, the main active component of WF10. Thus, pathologic, pro-inflammatory and auto-hemolytic effects of these products are diminished.
c) Blood rejuvenation
Chlorite also induces the selective removal of highly glycated, dysmorphic, pre-damaged, RBCs from the blood stream while inducing compensatory erythropoiesis. This drug-derived blood rejuvenation is reflected by a profound and long lasting HbA1c reduction while hematocrit (Hct) values remain stable.
d) Restoration of endothelial integrity
The causal treatment of diabetic vascular pathologies leads to restoration of endothelial integrity in diabetic patients.
3. Why using WF10 for DKD?
In summary, WF10 addresses multiple known risk-factors for DKD progression, including elevated HbA1c, lymphopenia and low ABI-values.
a) Chronic inflammation and resulting lymphopenia are common in DKD patients and lead to frequent infections and disease progression. WF10 will restore the healthy immune balance and immune competence.
b) Extravasation of RBCs and hemolytic products cause renal inflammation, resulting in further DKD progression. WF10 will break this cycle by removing hemolysis-prone highly glycated RBCs and hemolytic products.
4. Clinical implications for nephrologists
a) Senescent Cell Clearance as a Fibrosis Intervention
By eliminating pro-fibrotic senescent cells, the therapy tackles a root cause of DKD progression, reducing the patient’s risk to progress to End-Stage Renal Disease (ESRD).
b) Enhanced Renal Function and Protection
The positive eGFR slope and reduced albuminuria seen in small studies underscore the molecule’s ability to protect and restore kidney function.
c) Endothelial Repair and Oxygenation
Clearance of free hemoglobin and heme mitigates oxidative damage, improves microvascular function, and supports renal tissue repair.
d) Integrated Cardiorenal Benefits
Observed declines in NT-proBNP in treated patients indicate potential cardioprotective effects, complementing its renal benefits.