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Laekna Announces IND Acceptance by CDE for internally- discovered LAE 102 for the treatment of adult patients with obesity or metabolic diseases


February 28, 2024 — Laekna (2105.HK) announced that the Centre for Drug Evaluation of the National Medical Products Administration of China has accepted the Investigational New Drug application (IND) for LAE102, a potent, selective and internally discovered monoclonal antibody against ActRIIA, for the treatment of adult patients with obesity or metabolic diseases. In February 2024, the IND of LAE102 for solid tumor has been approved by the CDE.


The Company will work closely with the regulatory authorities to complete the application. Laekna would commence the clinical trial process after obtaining the IND approval and is committed to bring this precision therapy to obesity or metabolic patients who are in need of novel treatment options.


"We are delighted to witness LAE 102, one of Laekna’s internally-discovered preclinical candidates, advancing to the clinical stage,” said Dr. Chris Lu, Chief Executive Officer of Laekna, “Obesity is one of the focal points of global pharmaceutical development. Laekna will prioritize patient needs and accelerate the research and development in the field”.


LAE102 is a potent, selective and internally discovered monoclonal antibody against a novel target ActRIIA that has regulatory effects on muscle regeneration. It has shown in the pre-clinical studies to increase skeletal muscle and decrease white fat, a potential drug candidate to be developed for obesity and other metabolic disease indications. In obesity mouse models, LAE102 synergizes with GLP-1 in reducing fat mass and attenuates lean mass loss induced by GLP-1 to achieve quality weight loss.


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About Laekna


Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer and liver fibrosis patients worldwide.


As of June 30, 2023, Laekna has initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 to address unmet medical needs in cancers, such as ovarian cancer, breast cancer and prostate cancer. Among the six clinical trials, three are multi-regional clinical trials (MRCTs), including one pivotal trial.


Laekna’s internal drug discovery platform has discovered 12 drug candidates. LAE102 is our first internally discovered antibody which has obtained IND approvals from the FDA and CDE. Its potential indications include muscle regeneration, obesity, and cancer.


Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. The stock code is 2105.HK.


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