LAEKNA-B(02105): The positive top-line results of the Phase I SAD study of LAE102 in the United States present an encouraging trend of increasing muscle mass and reducing fat.

LAEKNA-B (02105) announced that the group has successfully completed Phase I dose escalation study of LAE102 in collaboration with Lilly in the United States (US SAD study). The US SAD study is a randomized, double-blind, placebo-controlled study, aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of LAE102 administered subcutaneously and intravenously in healthy postmenopausal women. The average BMI of the subjects enrolled was 26.99 kg/m2. The safety profile is consistent with previous study results, and the US SAD study further confirmed that LAE102 has good tolerability, with no reports of any serious adverse events. In terms of efficacy, the US SAD study showed that after a single dose, subjects exhibited encouraging improvements in body composition, with a dose-dependent increase in muscle and decrease in fat. On day 29 after a single dose of LAE102, the group with the highest exposure level showed an average increase of 5.06% in lean body weight from baseline (compared to a decrease of 1.34% in the placebo group) and a decrease of 0.12% in fat mass from baseline (compared to an increase of 2.11% in the placebo group). Single-dose LAE102 led to a significant and sustained increase in adiponectin levels, demonstrating strong target engagement. The duration of target engagement was dose-dependent. The group plans to present detailed study results at an upcoming scientific conference. These positive results further support LAE102 as an innovative therapy for cardiovascular metabolic diseases. The group is actively planning Phase II clinical trials to evaluate the combination therapy of LAE102 with incretin-based insulin drugs for patients with high BMI and related comorbidities. Currently, the group is actively negotiating with potential partners to accelerate the global development and commercialization process of LAE102. The group is committed to bringing this precision treatment to overweight and obese patients in need of new treatment options for achieving high-quality weight control.