February 28, 2024 - Laekna Pharma (2105.)HK) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the Investigational New Drug (IND) application for LAE102 in obesity. The drug is a potent and selective monoclonal antibody against Actriia independently developed by Laekna, and is potentially used in patients with obesity or metabolic diseases. Previously, the oncology investigational trial application for LAE102 was approved by the CDE in February 2024.
The company will communicate closely with regulators to initiate the LAE102 clinical trial process after the IND is approved, so as to provide a new and accurate ** option for patients with obesity or metabolic diseases.
LAE102 is one of the results of Laikai's independent research and development, and I am glad to see it move from the laboratory to the clinic step by step. "Dr. Xiangyang Lu, Chief Executive Officer of Laekna Therapeutics, said:"Obesity is one of the key areas of global biomedicine, and Laekna will take the needs of patients as the primary goal and make every effort to accelerate the research and development process in this field. "
LAE102 is a potent and selective monoclonal antibody targeting Actriia, a novel target that regulates muscle regeneration. In preclinical studies, LAE102 has been shown to increase skeletal muscle and reduce white fat and is a potential drug candidate for the development of indications for obesity and other metabolic diseases. In an obese mouse model, the combination of LAE102 and GLP-1** showed a synergistic effect to effectively increase fat loss while avoiding muscle loss, promising high-quality fat loss results.