On December 4, Gelonghui | LAEKNA-B (02105.HK) issued an announcement. The phase I clinical trial of LAE102 is progressing smoothly. As of the date of this announcement, all participants in the Phase I single-dose escalation study (“SAD Study”) (8 intravenous and subcutaneous incremental dose cohorts, 64 subjects in total) had completed administration and had observed early signs of target binding and changes in expected pharmacodynamic biomarkers, as well as good safety. This phase I clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of LAE102 injections in healthy adult subjects and overweight/obese subjects, respectively.
After completing the single-dose escalation study of the phase I clinical trial, the Group will launch a phase I multi-dose escalation study (“MAD study”) according to the plan to further evaluate tolerability and efficacy, and accelerate clinical development and commercial progress of LAE102. The Group is committed to bringing this precision treatment to overweight and obese patients who require novel treatment options to achieve high-quality weight control.
Furthermore, in a challenging macroeconomic environment, implementing strict and prudent financial management is the key to success. The Group has and will continue to maintain a strict development strategy to maintain the Group's healthy financial situation and stable cash flow performance, so that the Group has sufficient financial resources to support and accelerate the clinical development of LAE102.