Applied Therapeutics Announces Positive Results from Phase 3 Trial of AT-001 for Diabetic Cardiomyopathy
Applied Therapeutics, Inc. (Nasdaq:APLT), a clinical-stage biopharmaceutical company, has announced the topline results of their ARISE-HF Phase 3 trial for AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM). The results showed a strong trend in stabilizing cardiac functional capacity and preventing clinically significant worsening of the disease.
The primary endpoint of the study was stabilization or improvement in cardiac functional capacity as measured by Peak VO2 in patients treated with AT-001 1500mg twice daily (BID) as compared to placebo. The placebo-treated group declined by a mean of -0.31 mlkgmin over 15 months of treatment, while the AT-001 1500mg BID group remained primarily stable, with a mean change of -0.01 mlkgmin over 15 months. Although the difference between active and placebo treated groups (0.30 mlkgmin) was not statistically significant (p=0.210), a trend favored active treatment.
The ARISE-HF study evaluated the treatment effect of AT-001 as an add-on to diabetes standard of care therapies. In a pre-specified subgroup analysis of the primary endpoint in patients not concomitantly treated with SGLT2 or GLP-1 therapies, the placebo group declined by a mean of -0.54 mlkgmin, while the 1500mg BID AT-001 treated group improved by a mean of 0.08 mlkgmin over 15 months of treatment, with a difference between groups of 0.62 mlkgmin (p=0.040). This subgroup analysis also showed a lower incidence of clinically significant worsening of disease in the AT-001 treated group.
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. The full study results, including the Diabetic Peripheral Neuropathy sub-study, will be presented at an upcoming medical conference.
“We are pleased with the positive results from our ARISE-HF Phase 3 trial for AT-001 in patients with Diabetic Cardiomyopathy,” said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. “These results demonstrate the potential of AT-001 to stabilize cardiac functional capacity and prevent worsening of disease, particularly in patients not on concomitant treatment with an SGLT2 or GLP-1. We believe that AT-001 has the potential to be an important treatment option for physicians and patients.”
There are currently no approved therapies for Diabetic Cardiomyopathy, highlighting the high unmet need for a treatment that can improve outcomes for these patients. Applied Therapeutics is committed to developing innovative treatments for conditions with high unmet medical need, and the positive results from their Phase 3 trial for AT-001 are a significant step towards achieving this goal.
Applied Therapeutics has announced positive results from their Phase 3 trial for AT-001 in patients with Diabetic Cardiomyopathy.
