Applied Therapeutics to Present Baseline Data on the Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association

• The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the safety and efficacy of AT-001 (caficrestat) in improving or preventing worsening of cardiac functional capacity in Diabetic Cardiomyopathy (DbCM); topline data from the study is expected in the fourth quarter of this year
• Baseline data from ARISE-HF shows a strong statistical correlation between elevations in the cardiac stress biomarker, NT-proBNP, reduced cardiac functional capacity and physical activity, underscoring the importance of early diagnosis via NT-proBNP and impact of DbCM on physical function and quality of life

NEW YORK, June 22, 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 multiple presentations on AT-001 (caficrestat) and the ARISE-HF Phase 3 study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association to take place June 23 – 26 in San Diego, California.

Oral Symposium: Early Diagnosis of Diabetes Cardiomyopathy (DbCM)—What Can Be Done?
Cross-Sectional Analysis of a Large Cohort of Patients with DbCM Enrolled in a Longitudinal Study – Baseline Results of the ARISE-HF Trial
Justin Ezekowitz, MB, BCh, MSc, FACC, FESC, FAHA
University of Alberta
Monday, June 26, 2023; 3:15pm – 3:30pm (Pacific), Room 24

The Face of Diabetic Cardiomyopathy: Baseline Characteristics from the ARISE-HF Trial
Javed Butler, Stefano Del Prato, Justin Ezekowitz, Nasrien E. Ibrahim, Carolyn S. Lam, Riccardo Perfetti, Julio Rosenstock, W.H. Wilson Tang, Alessia Urbinati, Faiez Zannad, James L. Januzzi, Jr.        

Saturday, June 24, 2023, 11:30 AM – 12:30 PM (Pacific), Poster 1238

N-Terminal Pro-B Type Natriuretic Peptide Concentrations in Diabetic Cardiomyopathy: Baseline Data from the ARISE-HF Trial
Javed Butler, Stefano Del Prato, Justin Ezekowitz, Nasrien E. Ibrahim, Carolyn S. Lam, Riccardo Perfetti, Julio Rosenstock, W.H. Wilson Tang, Alessia Urbinati, Faiez Zannad, James L. Januzzi, Jr.

Monday, June 26, 2023, 11:30 AM – 12:30 PM (Pacific), Poster 450

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.

Forward-Looking Statements

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Contacts

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

Media: 
media@appliedtherapeutics.com 

Applied Therapeutics, Inc.