LAEKNA-B (02105.HK): LAE103 phase I SAD study completed
- The randomised, double-blind, placebo-controlled study in Australia assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous LAE103.
- Single doses caused no serious adverse events and no discontinuations, with clear target engagement and expected pharmacodynamic biomarker changes.
NewTimeSpace News: On 9 November 2026, Laekna, Inc. (Stock Code: 02105) said it completed a phase I single-ascending-dose (SAD) study of LAE103, an anti-ActRIIB monoclonal antibody, in overweight or obese subjects in Australia. The randomised, double-blind, placebo-controlled trial assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of the subcutaneous drug.
The announcement shows single subcutaneous doses were well tolerated, with no serious adverse events and no discontinuations for adverse events. The study observed clear target engagement and expected pharmacodynamic biomarker changes, dose-proportional pharmacokinetics and a clear PK/PD relationship, supporting once-monthly subcutaneous dosing and strong developability. LAE103 targets ActRIIB for sarcopenic obesity and other muscle-related diseases. The company cautioned that LAE103 may not ultimately be developed or commercialised.
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