- To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in 60 overweight/obese subjects

- Robust SAD study data has established a solid foundation for the coming MAD Study

- The Phase I clinical trial of LAE102 in the U.S is expected to commence in Q2 of 2025

March 26, 2025 — Laekna (2105.HK) announced that subject recruitment for the Phase I multiple ascending dose study of LAE102(monoclonal antibody against ActRIIA) for the treatment of obesity (the MAD study) has commenced. The first visit for the first subject has been completed.

The MAD Study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in 60 overweight/obese subjects.

Dr. Chris Lu, Chairman of Laekna, said: " The positive outcomes of the SAD Study of LAE102 have established a solid foundation for the Phase I MAD study. The data demonstrated an encouraging safety and tolerability profile. Robust target engagement and expected pharmacodynamic biomarker changes have been observed.” He stated that the detailed results of the SAD study will be presented at an international scientific conference this year. Phase I clinical trial of LAE102 in the U.S is expected to commence in the second quarter of 2025.

LAE102 is Laekna’s 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 November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company (NYSE: LLY) to support and accelerate global clinical development of LAE102 for the treatment of obesity.  

Laekna team has accumulated tremendous experience and extensive knowhow in the specific field of targeting ActRII receptors and is developing, in addition to LAE102, more drug candidates 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 and target to submit IND applications in 2025.

-  End –

About 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.

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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/

Forward-Looking Statements

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