A single intravenous infusion of JK07 was safe and well tolerated at doses up to 0.09 mg/kg in patients with HFrEF, with exploratory improvements observed in left ventricular ejection fraction.
RCT (n=14)
Double-blind
3:1
Yes
Does a single ascending dose of the selective ErbB4 agonist JK07 demonstrate safety, tolerability, and exploratory efficacy in patients with HFrEF?
A single intravenous dose of the selective ErbB4 agonist JK07 was safe up to 0.09 mg/kg in HFrEF patients and demonstrated exploratory signals of prolonged LVEF improvement, supporting further clinical investigation.
This first-in-human, phase 1, double-blind, placebo-controlled study evaluated the safety, tolerability, immunogenicity, pharmacokinetics, and exploratory efficacy of a selective ErbB4 agonist, JK07, in patients with heart failure with reduced ejection fraction (HFrEF). In these patients on optimal goal-directed medical therapy, JK07 was generally safe and well tolerated at dose levels up to 0.09 mg/kg. There was a trend toward increased incidence and severity of treatment-emergent adverse events observed at the highest dose of 0.27 mg/kg. Consistent with prolonged effects seen with transient exposure to neuregulin-1 in previous phase 1 investigations, improvements in left ventricular ejection fraction lasting up to 180 days after infusion were observed. These findings support continued clinical investigation of JK07 in heart failure. (Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction; NCT04210375).
Tang et al. (Tue,) conducted a rct in Heart Failure With Reduced Ejection Fraction (HFrEF) (n=14). JK07 vs. Placebo was evaluated on Incidence and severity of treatment-emergent adverse events (TEAEs). A single intravenous infusion of JK07 was safe and well tolerated at doses up to 0.09 mg/kg in patients with HFrEF, with exploratory improvements observed in left ventricular ejection fraction.