LAEKNA-B (02105) Reports Encouraging Muscle-Building and Fat-Reducing Trends from US Phase I SAD Study of LAE102

Stock News
03/10

LAEKNA-B (02105) announced the successful completion of the Phase I Single Ascending Dose study of LAE102 in the United States, conducted in collaboration with Eli Lilly. The US SAD study was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE102 administered via subcutaneous and intravenous routes in healthy postmenopausal women. The average BMI of enrolled subjects was 26.99 kg/m². The safety profile was consistent with previous study results, and the US SAD study further confirmed that LAE102 was well-tolerated with no serious adverse events reported. In terms of efficacy, the US SAD study demonstrated encouraging improvements in body composition following a single dose, with observed dose-related increases in muscle mass and reductions in fat. On day 29 after a single dose of LAE102, the group with the highest exposure showed an average increase in lean body mass of 5.06% from baseline (compared to a 1.34% decrease in the placebo group) and an average reduction in fat mass of 0.12% from baseline (compared to a 2.11% increase in the placebo group). A single dose of LAE102 led to a significant and sustained increase in activin A levels, indicating strong target engagement. The duration of target engagement was dose-dependent. The company plans to present detailed study results at an upcoming scientific conference. These positive results further support LAE102 as an innovative therapy for cardiometabolic diseases. The company is actively planning a Phase II clinical trial to evaluate LAE102 in combination with incretin-based therapies for patients with higher BMI and related comorbidities. Currently, the company is engaged in active discussions with potential partners to accelerate the global development and commercialization of LAE102. The company is committed to delivering this precision treatment to overweight and obese patients in need of new therapeutic options for high-quality weight management.

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