NEW YORK, Dec. 06, 2019 (GLOBE NEWSWIRE) -- Applied Therapeutics Inc. (APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the presentation of data at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) in Los Angeles (December 4-7, 2019) on AT-001, a novel, potent and selective aldose reductase inhibitor (ARI) in Phase 3 clinical development for Diabetic Cardiomyopathy (DbCM).
“The Aldose Reductase enzyme has long been known to play a key role in several diabetic complications, including DbCM," said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. "Unfortunately, past attempts to inhibit Aldose Reductase failed due to lack of selectivity and off-target toxicity. AT-001 was designed based on new structural understanding of the AR enzymatic site, resulting in significantly increased potency and selectivity. The pre-clinical data we are presenting at WCIRDC shows the head to head comparison of AT-001 vs. a first-generation Aldose Reductase inhibitor and highlights the improvements over these prior ARIs.”
Overcoming the Safety Challenges of Aldose Reductase Inhibition: Development of AT-001 for Diabetic Cardiomyopathy (#068)
(poster presentation Thursday, Dec 5th, from 6:30-7:30pm; oral presentation Friday, Dec 6th, from 6:45-8:15pm)
- AT-001 is logarithmically more potent than zopolrestat in inhibiting Aldose Reductase
- The unique structure and activity of AT-001 provide selectivity for Aldose Reductase and avoid off-target inhibition of Aldehyde Reductase
- The in vitro safety of this agent together with the positive safety data from the phase 1/2 program, support the ongoing pivotal study in DbCM
The presentation will be available on the Applied Therapeutics website following the oral session.
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 hallmark of 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 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.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The company’s lead drug candidate, AT-001, is a novel aldose reductase inhibitor (ARI) that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The company initiated a Phase 3 registrational study in DbCM in September 2019. Applied Therapeutics is also developing AT-007, a central nervous system penetrant ARI, for the treatment of Galactosemia, a rare pediatric metabolic disease, and initiated a Phase 1/2 clinical trial in June 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, expected to advance into a Phase 1 study in 2020.
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