Applied Therapeutics Announces IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients
New AT-001 IND opened with FDA for acute lung inflammation and cardiomyopathy in critical COVID-19 patients
“Our mission is to develop life-saving drugs for patients in desperate need of treatment,” said
AT-001 is an investigational novel Aldose Reductase Inhibitor (ARI) in Phase 3 development in the US,
COVID-19 can cause significant cardiac morbidities, including cardiomyopathy. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, and is highly expressed in the heart and lungs. Binding of the virus to ACE2 is believed to lead to cardiomyocyte damage, in part due to cytokine-mediated oxidative stress. AT-001, a novel and potent aldose reductase inhibitor, has been shown to prevent oxidative damage to cardiomyocytes, and decrease oxidative-induced damage.
In severe cases, COVID-19 infection can lead to development of Acute Respiratory Distress Syndrome (ARDS) and Acute lung Inflammation/Injury (ALI) resulting from inflammatory response. In an animal model of sepsis-induced ALI, Aldose Reductase inhibition was shown to have a beneficial effect and attenuate severity of disease by reducing cytokines (such as IL-6), neutrophil infiltration into the lungs, and activation of lung inflammatory endothelial cells.
AT-001 is an investigational oral, novel, potent Aldose Reductase inhibitor in Phase 3 clinical development for the treatment of Diabetic Cardiomyopathy. AT-001 has been previously 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