AT-001 is an investigational, novel Aldose Reductase Inhibitor (ARI) developed as an oral therapy for the treatment of Diabetic Cardiomyopathy (DbCM)

AT-001 was evaluated in the ARISE-HF Phase 3 study in patients with DbCM. The global ARISE-HF Phase 3 study evaluated the ability of AT-001 to improve or 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. The study demonstrated a positive impact of AT-001 treatment, which was statistically significant in a prespecified subgroup of patients not on concomitant treatment with an SGLT2 or GLP-1 inhibitor. 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.

AT-001 was generally safe and well tolerated, with no substantial differences in serious adverse events between AT-001 treated groups as compared to placebo and low incidence of treatment-related discontinuations.