Applied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual Meeting

• The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the efficacy of AT-001 (caficrestat) on cardiac functional capacity in patients with diabetic cardiomyopathy (DbCM)
• Baseline data from ARISE-HF shows patients with DbCM exhibit reduced cardiac functional capacity resulting in decreased physical activity

NEW YORK, Sept. 28, 2023 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: 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 it will participate in a Symposium presentation, entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes, at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting to take place October 2-6, 2023 in Hamburg, Germany and online.

“Patients with diabetes are at a high risk of developing overt heart failure even when optimal glucose control is achieved,” said Riccardo Perfetti, MD, PhD, Chief Medical Officer at Applied Therapeutics. “Diabetic Cardiomyopathy (DbCM) is a severe disease affecting approximately 20% of patients with diabetes. The Phase 3 ARISE-HF study is investigating the potential benefit of AT-001 in treating DbCM, and we look forward to the data readout later this year.”

Symposium presentation agenda

Diabetic Cardiomyopathy (DbCM): A Severe Complication of Diabetes
Thursday, October 5

5:30PM – 5:35PM
Introduction
Stefano Del Prato, MD, Chief of the Section of Diabetes, University Hospital of Pisa, Italy

5:35PM – 5:55PM
Diabetic Cardiomyopathy: Molecular Mechanism
Gary Lopaschuk, PhD, Professor, Department of Pediatrics, University of Alberta, Edmonton, Canada
Scientific Director, Mazankowski Alberta Heart Institute

5:55PM – 6:15PM
Diagnosis of Diabetic Cardiomyopathy Based on Circulating Markers of Disease: Lessons from the Baseline Analysis of the ARISE-HF Study
Riccardo Perfetti, MD, PhD, Chief Medical Officer, Applied Therapeutics, New York City, USA

6:15PM – 6:30PM
Questions and Answers

About AT-001
AT-001 (also called caficrestat) is an investigational oral, novel, potent Aldose Reductase inhibitor in Phase 3 clinical development for the treatment of Diabetic Cardiomyopathy. The global ARISE-HF study is currently ongoing, and is designed to evaluate the ability of AT-001 to improve or prevent worsening of disease, as measured by changes in cardiac functional capacity, in approximately 675 patients with DbCM at high risk of progression to overt heart failure. 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, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. 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.

To learn more, please visit www.appliedtherapeutics.com and follow the company on Twitter @Applied_Tx.

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Contacts

Investors:
Maeve Conneighton
(212) 600-1902
appliedtherapeutics@argotpartners.com

Media:
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Applied Therapeutics, Inc.