Full enrollment in the registrational phase III ARISE-HF trial of AT 001 in diabetic cardiomyopathy
Applied Therapeutics, Inc. announced full enrollment in the Phase III registrational ARISE-HF trial, studying AT 001, a selective Aldose Reductase inhibitor, in patients with Diabetic Cardiomyopathy (DbCM)
The ARISE-HF study is a randomized double-blind placebo-controlled Phase III registrational trial. The study enrolled 675 patients with DbCM at high risk of progression to overt heart failure in the US, EU, UK, Canada, Australia and Hong Kong. The primary endpoint is cardiac functional capacity (as measured by Peak VO2) at 15 months of treatment. Topline data is expected around year-end 2023 or early 2024, and if positive, the company plans to submit for potential regulatory approval. Patients will continue in blinded format for an additional 12 months of treatment (up to 27 months total) to produce secondary endpoint data on progression to overt heart failure, hospitalization, morbidity and mortality, which is not anticipated for regulatory approval, but will support long-term market access. The ARISE-HF trial also includes an embedded sub-study in patients with both DbCM and Diabetic Peripheral Neuropathy evaluating the impact of AT001 on neuropathy progression.
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