DM199 for Diabetic Kidney Disease (DKD)

Lasting Improvements in Kidney Function

DM199 is intended to restore normal levels of KLK1 and stimulate nitric oxide and prostaglandin production to improve blood flow and reduce oxidative stress, inflammation and renal fibrosis in the kidneys. Preliminary data demonstrate significant improvement in kidney function in DKD patients taking DM199.

Pipeline

Program Asset Route of Admin Development Stage
Preclinical Phase 1 Phase 2 Phase 3
Neurological
Acute Ischemic Stroke DM199 IV/SC
REMEDY Phase 2/3 Study Preclinical complete
Phase 1 complete
Phase 2 in progress
Phase 3 not started
Kidney Diseases
IgA Nephropathy DM199 SC
REDUX Phase 2 Study Preclinical complete
Phase 1 complete
Phase 2 in progress
Phase 3 not started
African Americans with CKD DM199 SC
REDUX Phase 2 Study Preclinical complete
Phase 1 complete
Phase 2 in progress
Phase 3 not started
Other
Additional Recombinant Protein DM300
Preclinical Preclinical in progress
Phase 1 not started
Phase 2 not started
Phase 3 not started

About Diabetic Kidney Disease (DKD)

Diabetic kidney disease (DKD) is a progressive disorder that occurs in up to 40% of people with diabetes1. Its prevalence parallels the rise in rates of diabetes worldwide. DKD is characterized by a decline in kidney function, reduced quality of life, organ damage and potentially renal failure requiring transplantation or dialysis. It is the leading cause of chronic kidney disease, for which currently, there is no cure.

1. Alicic RZ, Rooney MT, Tuttle KR. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin. J. Am. Soc. Neprol. 2017; 12 (12): 2032-2045.

Market Need

  • 40% of diabetic patients (12 million in the U.S.)
  • Most frequent cause of end-stage renal disease worldwide
  • Current standard of care includes anti-hypertensives and SGLT2 inhibitors to slow the progression of the disease

Mechanism of Action

Potential Benefits of DM199 for DKD

  1. Regulate blood flow:

    • Improve micro vascularization
    • Increases oxygen and nutrients
  2. Improve glomerular function:

    • Reduce inflammation, oxidative stress and fibrosis
    • Prevent or reduce thickening of glomerular basement membrane
    • Inhibit mesangial cell proliferation
  3. Regulate epithelial sodium channel (ENaC):

    • Regulate salt & water reabsorption and excretion
  4. Increase T-regs (CKD autoimmune diseases)

    • Halt pathological autoimmune attack on glomerulus

Clinical Studies

DiaMedica is currently sponsoring clinical trials of DM199 for the treatment of DKD. Patients will receive DM199 as a subcutaneous injection. Researchers will assess patients’ albuminuria and eGFR (blood flow through the kidney) to evaluate changes in kidney function.