Applied Therapeutics, a clinical-stage biopharmaceutical company, faced stock decline after unveiling the topline results of the ARISE-HF Phase 3 trial for its drug AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM) at high risk of progressing to overt heart failure. The trial failed to meet its primary endpoint of stabilizing or improving cardiac functional capacity when compared to a placebo.
The primary objective of the study was to assess the impact of AT-001 1500mg twice daily (BID) on cardiac functional capacity, measured by Peak VO2, in comparison to a placebo. The placebo-treated group exhibited a mean decline of -0.31 ml/kg/min over the 15-month treatment period, while the AT-001 1500mg BID group showed primarily stable results, with a mean change of -0.01 ml/kg/min over the same duration. Although a favorable trend towards active treatment was observed, the difference between the active and placebo-treated groups (0.30 ml/kg/min) did not reach statistical significance (p=0.210).
Commenting on the results, Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics, stated, “AT-001 stabilized cardiac functional capacity as compared to placebo and prevented clinically significant worsening of disease, an effect which was strengthened in patients not on concomitant treatment with an SGLT2 or GLP-1. Given its favorable safety and tolerability profile and oral dosing, we believe that AT-001 represents an important potential tool for physicians in the treatment of DbCM patients. We thank the patients and families who participated in the ARISE-HF study and made this important work possible.”
Despite the failure to meet the primary endpoint, Applied Therapeutics remains committed to further developing AT-001. The company believes that the drug’s ability to stabilize cardiac functional capacity could offer assistance to Diabetic Cardiomyopathy patients, especially in the absence of approved therapies for this condition.
The market response to the announcement was evident in Applied Therapeutics’ stock performance. The stock experienced a decline, opening at $2.17 on Monday after closing Friday’s session at $2.25.
At the time of this publication, Applied Therapeutics Inc stock (APLT) has witnessed a decline.
Applied Therapeutics Inc
Current Price: $1.87
Change : -0.38
Change (%): (-16.89%)
Volume: 1.0M
Source: Tomorrow Events Market Data
Stock Performance of Applied Therapeutics:
– 5 Day: -39.40%
– 1 Month: -32.33%
– 3 Month: -17.14%
– YTD: -39.40%
– 1 Year: 105.03%
Applied Therapeutics acknowledges the challenges ahead but remains optimistic about the potential of AT-001 in addressing the unmet medical needs of Diabetic Cardiomyopathy patients. The company will continue its efforts to bring this novel therapeutic option to fruition, guided by the insights gained from the ARISE-HF Phase 3 trial.
