Benzinga | Jun 25, 2021 12:07PM EDT

Applied Therapeutics Announces Presentation of Data on the Prevalence of Diabetic Cardiomyopathy at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association

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 data presentations confirming the high prevalence of Diabetic Cardiomyopathy (DbCM) in adults with diabetes or pre-diabetes. The studies, which were performed by independent investigators under research grants sponsored by Applied Therapeutics, will be presented at the 81st Scientific Sessions of the annual 2021 American Diabetes Association meeting taking place virtually June 25-29.

Presentation Details

978-P "Prevalence, Optimal Screening Approaches, and Prognostic Implications of Diabetic Cardiomyopathy in Community-Dwelling Adults."

* Individuals with diabetes or pre-diabetes have abnormalities in several measures of cardiac structure, function and biomarkers

* Based on analyses of 3 studies comprising 16,653 participants without cardiovascular disease or heart failure at baseline, the prevalence of DbCM was 17% in people with diabetes or pre-diabetes and two or more cardiac abnormalities on echocardiogram (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction), representing a prevalence of ~1 in 5 people with diabetes

971-P "Prevalence of Diabetic Cardiomyopathy in real-world practice: a longitudinal cohort study"

* To determine the prevalence of DbCM, an analysis was completed among Type 2 Diabetic patients who had not yet progressed to overt Heart Failure and who had echocardiography at the University of California San Diego Medical Center in the period from 2010 to 2015

* As Left Atrial Enlargement (LAVI) represents a widely used and documented echocardiographic criteria, this was utilized in the UCSD database as the echocardiographic indicator of DbCM

* When looking at LAVI only (not including other echocardiographic indicators of DbCM), the prevalence of DbCM in this sub-population was 9%

1043-P "Prevalence of Diabetic Cardiomyopathy: A systematic review of the literature"

* A systematic literature review was conducted for studies that reported the epidemiology of DbCM

* With an estimated 61 million diagnosed diabetics across the United States, France, Germany, Italy, Spain, United Kingdom and Japan, this analysis estimates that ~ 1 in 5 patients with diabetes, or 12.9 million people in these countries meet echocardiographic criteria for DbCM, with 10.7M of this population also meeting the criteria for stage B heart failure, I.E., structural heart disease prior to development of overt heart failure

"These new data confirm the high prevalence of Diabetic Cardiomyopathy, which is a major health issue that will continue to grow as the population of people with diabetes increases," said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. "It is important for healthcare professionals to be aware of risk factors and to screen for Diabetic Cardiomyopathy, a serious and progressive disease that can lead to increased hospitalizations, morbidities and mortality."

"The high prevalence of Diabetic Cardiomyopathy underscores the urgent need for clinical intervention," said Shoshana Shendelman, PhD, Founder and Chief Executive Officer of Applied Therapeutics. "The ARISE-HF global registrational study evaluating AT-001 treatment in Diabetic Cardiomyopathy represents a major advancement for both patients and physicians. The study is currently enrolling at 82 sites worldwide. To learn more or to enroll or refer patients, please visit www.ARISEHF.com."

About AT-001

AT-001 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 prevent worsening of disease, as measured by changes in cardiac functional capacity, in 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.