Applied Therapeutics shares plunged almost 35% after the biotechnology firm reported disappointing results from its Phase 3 heart disease trial.
The company reported that its ARISE-HF trial of drug candidate AT-001 (caficrestat) in patients with diabetic cardiomyopathy (DbCM) at high risk of progressing to overt heart failure did not meet its primary endpoint of stabilization or improvement in cardiac functional capacity as measured by peak VO2.
It said the placebo-treated group declined by a mean of -0.31 ml/kg/min over 15 months of treatment, while the AT-001 1500mg BID group remained primarily stable, with a mean change of -0.01 ml/kg/min over 15 months.
“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,” Applied Therapeutics’ chief medical officer Dr. Riccardo Perfetti said in a statement.
“Given its favorable safety and tolerability profile and oral dosing, we believe that AT-001 represents an important potential tool for physicians in treatment of DbCM patients.”
Applied Therapeutics said it will focus on identifying a partner to continue to progress the drug and bring it to DbCm patients.
Shares of the company were down 34.6% at US2.48 late morning on Friday.