Phase 3 ARISE-HF Study Outcomes for Diabetic Cardiomyopathy to be Presented at ACC 2024

Applied Therapeutics, a biopharmaceutical firm, is set to unveil comprehensive findings from the Phase 3 ARISE-HF study at the 2024 American College of Cardiology's Annual Scientific Session. The study focuses on AT-001, an investigational drug for Diabetic Cardiomyopathy (DbCM), a severe cardiac condition. The company had previously announced that AT-001 showed promising signs of stabilizing heart function and significantly improved outcomes in a subgroup of patients not concurrently using SGLT2 or GLP-1 medications.

The upcoming presentation will delve into data concerning the progression to overt heart failure and other secondary measures, revealing that AT-001 effectively curbed this progression in DbCM patients compared to a placebo. The drug's safety profile will also be highlighted, with evidence indicating that it was well-tolerated among a large patient group, addressing previous concerns related to selectivity and safety of aldose reductase inhibitors.

AT-001, currently in Phase 3 trials, is an innovative oral Aldose Reductase inhibitor being developed to treat DbCM. The ARISE-HF study involved 675 high-risk DbCM patients and demonstrated a positive effect of AT-001, particularly in those not taking SGLT2 or GLP-1 inhibitors. The drug has also been studied in a Phase 1/2 trial involving around 120 patients with type 2 diabetes, some of whom had DbCM.

Applied Therapeutics is dedicated to developing novel drug candidates for conditions with significant unmet medical needs. Its lead candidate, govorestat, is designed to treat rare CNS metabolic diseases, while AT-001 is specifically aimed at DbCM. The company's preclinical pipeline also includes AT-003, which is intended for the treatment of Diabetic retinopathy.

The presentation at ACC will be conducted by a team of renowned experts and will be followed by a publication of the study results in the Journal of the American College of Cardiology. This event underscores the company's commitment to advancing treatment options for patients with DbCM and contributing to the broader medical community's understanding of this condition.