Laekna, Inc. (stock code 02105, listed as Laekna-B) released voluntary topline data indicating that its internally discovered monoclonal antibody LAE102 achieved clinically relevant body-composition improvements in a U.S. Phase I single-ascending-dose (SAD) study conducted with Eli Lilly and Company.
The randomized, double-blind, placebo-controlled trial evaluated subcutaneous and intravenous administrations of LAE102 in healthy postmenopausal women (average BMI 26.99 kg/m²). The compound demonstrated a well-tolerated safety profile with no serious adverse events reported.
Efficacy signals showed clear dose dependence: • Day 29 post-dosing, the highest-exposure cohort recorded a 5.06% increase in mean lean body mass versus a 1.34% decrease in the placebo group. • Mean fat mass declined 0.12% in the same cohort, compared with a 2.11% increase under placebo.
Pharmacodynamic analysis revealed significant, sustained activin A elevations, confirming robust target engagement; duration of engagement correlated with dose level.
Building on these findings, Laekna plans Phase 2 trials positioning LAE102 as an add-on to incretin therapies for patients with higher BMI and cardiometabolic comorbidities. Concurrently, the company is in discussions with potential partners to speed global development and commercialisation.
LAE102 targets the ActRIIA receptor, a key regulator of muscle regeneration and lipid metabolism. Pre-clinical data suggest the antibody increases lean mass, reduces fat mass, and counteracts lean-tissue loss associated with GLP-1 receptor agonists, supporting its potential for “quality” weight control.
Risk statement: LAE102 may not ultimately achieve successful development or commercialisation; shareholders and investors are advised to exercise caution when dealing in Laekna-B securities.