May 28, 2025 — Laekna, Inc. (2105.HK) (“Laekna”) today announced that the first subject has been dosed in phase I clinical trial of LAE102, an internally discovered monoclonal antibody selectively targeting ActRIIA, in U.S. (the “U.S. Phase 1 Clinical Trial”). The Group targets to achieve primary completion of the U.S. Phase I Clinical Trial in September 2025.

Meanwhile, the Group has commenced a Phase I multiple ascending dose study of LAE102 in China and remains on track to have preliminary data from its Phase I multiple ascending dose study ready by the end of September 2025.

"We are thrilled to collaborate with Lilly, a global leader in the field of obesity and metabolic diseases, to introduce cutting-edge treatment to obesity patients," said Dr. Chris Lu, Chairman and Chief Executive Officer of Laekna. "The project team was able to achieve the first patient visit in just over 7 weeks from protocol approval and first patient dosed in just over 10 weeks.  These are remarkable milestones, and we are so proud of this amazing accomplishment.  We appreciate the serious commitments of Lilly team to accelerate clinical development of LAE102."

LAE102 is an internally discovered monoclonal antibody selectively targeting ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism. In the pre-clinical models, LAE102 has been shown to increase lean mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and significantly regain the lean mass loss induced by GLP1R agonist. This positions LAE102 as a promising drug candidate for achieving quality weight control. 

In April 2024, the Group has obtained the IND approval from the U.S. FDA for LAE102 for the treatment of obesity. In November 2024, the Group entered into a clinical collaboration with Eli Lilly and Company (“Lilly”) , through its Lilly Catalyze360™ model, to support and accelerate global clinical development of LAE102 for the treatment of obesity. The Group retains global rights for LAE102.

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Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world.

As of December 31, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib), LAE001 and LAE005 to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

Laekna team has accumulated tremendous experiences and deep know-how in the specific field of targeting ActRII receptors and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other seven pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

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

For more information, please visit: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

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