Our clinical trials are designed to incorporate home visits to limit travel and risk of exposure to COVID-19.
Applied Therapeutics has completed a Phase 1/2 study of AT-007 in adults (age 18 and older) with Galactosemia. ACTION-Galactosemia evaluated the safety and pharmacokinetics (PK) of AT-007, a central nervous system (CNS) penetrant Aldose Reductase Inhibitor, in healthy volunteers, and explored safety, PK and biomarker effects in adult subjects with Galactosemia. Applied Therapeutics is now conducting a long-term extension with adult study participants.
Applied Therapeutics is currently conducting a pediatric study of AT-007 in children (age 2-17) with Galactosemia. Similar to the ACTION-Galactosemia trial in adults, the pediatric study will evaluate safety, pharmacokinetics, and reduction in the toxic biomarker, galactitol as well as long-term clinical outcomes, such as speech, memory, cognition, behavior, growth and development, and motor skills.
Applied Therapeutics is currently enrolling a Phase 3 clinical trial of AT-001 in adults with Type 2 Diabetes for Diabetic Cardiomyopathy (DbCM). ARISE-HF is evaluating whether AT-001 can improve or prevent the decline of functional capacity in patients with DbCM.