Applied Therapeutics Announces Initiation of Phase 3 Registrational Trial of AT-001 in Diabetic Cardiomyopathy (ARISE-HF)
Aldose reductase (AR) activity has been implicated as a strong contributing factor to pathogenesis in DbCM, a fatal fibrosis of the heart that occurs in both type 1 and type 2 diabetic patients, which leads to decreased contractility and decreased heart function, eventually resulting in overt heart failure. DbCM affects 17 – 24 percent of people with diabetes, or approximately 77 million patients worldwide.
ARISE-HF is a double-blind, placebo controlled, Phase 3 registrational trial expected to enroll approximately 675 type 2 diabetic patients with DbCM at high risk of progression to overt heart failure. ARISE-HF will assess AT-001’s ability to improve or prevent decline in exercise tolerance as measured by maximum amount of oxygen a person can utilize during intense exercise (peak VO2) over 15 months of treatment. The ARISE-HF trial will be conducted at approximately 70 centers in
“We are excited to announce the initiation of ARISE-HF, our pivotal trial in Diabetic Cardiomyopathy,” said
About Diabetic Cardiomyopathy
Diabetic Cardiomyopathy (DbCM) is a rapidly progressing degenerative disorder of the heart in patients with both type 1 and type 2 diabetes. There are no approved therapies for this fatal condition, which affects 17 – 24 percent of people with diabetes, or approximately 77 million patients worldwide. Hyperglycemia, a symptom that characterizes diabetes, triggers the enzyme Aldose Reductase to convert excess glucose into sorbitol and fructose, both of which can lead to cell death in the heart muscle. When this happens, the heart fibroses, or “hardens,” such that the organ is unable to circulate blood through the body effectively. Approximately 25 percent of patients with DbCM progress to overt heart failure or death within 1.5 years of diagnosis.
AT-001 is an investigational oral, novel, potent Aldose Reductase inhibitor in clinical development for the treatment of Diabetic Cardiomyopathy. AT-001 has been studied in a Phase 1/2 study in approximately 120 patients with type 2 diabetes, a subset of which had DbCM.
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Source: Applied Therapeutics