Diabetic Cardiomyopathy (DbCM) is a form of heart failure (Stage B) characterized by a decrease in heart function and diagnosed by echocardiogram.
Our Commitment to DbCM Research
Applied Therapeutics is committed to advancing research in DbCM and potentially finding a new treatment option for this urgent unmet medical need.
AT-001 was evaluated in a Phase 1/2 clinical trial of patients with type 2 diabetes (T2D). Results confirmed that AT-001 was well tolerated and significantly reduced levels of sorbitol, a key toxic biomarker of Aldose Reductase function, to the same levels as healthy volunteers, indicating complete Aldose Reductase inhibition. AT-001 rapid-release capsules provided sorbitol normalization effects through 10-12hrs post-dose at >10mg/kg. This included protection from food-related sorbitol spikes during times of post-prandial hyperglycemia. Additionally, approximately 50% of AT-001 treated patients demonstrated a clinically meaningful reduction in NT-proBNP, a biomarker of cardiac stress, over 28 days.
AT-001 is in Phase 3 clinical development for the treatment of Diabetic Cardiomyopathy. The global ARISE-HF study is fully enrolled, currently ongoing, and is designed to evaluate the ability of AT-001 to prevent worsening of disease, as measured by changes in cardiac functional capacity, in 675 patients with DbCM at high risk of progression to overt heart failure.