LAEKNA-B (02105): Phase I SAD study of LAE103 in overweight or obese subjects successfully completed

LAEKNA-B (02105) announced that the Group has successfully completed a Phase I single ascending dose (SAD) study of LAE103 (an ActRIIB monoclonal antibody) in overweight or obese subjects in Australia. The SAD study was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE103 (subcutaneous injection) in overweight or obese subjects. A single subcutaneous dose of LAE103 was well tolerated and safe, with no serious adverse events reported and no reports of dosing discontinuation due to adverse events. The study observed clear target engagement and expected pharmacodynamic biomarker changes. A single dose of LAE103 demonstrated dose-proportional pharmacokinetic characteristics and a clear pharmacokinetic/pharmacodynamic correlation, demonstrating that LAE103 has the therapeutic potential for once-monthly subcutaneous dosing and excellent drug developability.