- 64 subjects dosed in total of 8 IV and SC ascending dose cohorts

- Early signs of target engagements and expected pharmacodynamic biomarker changes have been observed with a generally accepted safety profile

- To commence the phase I multiple ascending dose study (“MAD Study”) right after completing the SAD study

December 4, 2024 — Laekna, Inc. (2105.HK) (“Laekna”) today announced that the phase I clinical trial of LAE102, a novel Activin Receptor Type 2 A (ActRIIA) is progressing effectively. As of today, all of the 64 subjects in total of 8 IV and SC ascending dose cohorts of the phase I single ascending dose study (the “SAD Study”) have been dosed.

Early signs of target engagements and expected pharmacodynamic biomarker changes have been observed with a generally accepted safety profile.

The phase I clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of LAE102, administered both intravenously and subcutaneously, in healthy subjects and overweight/obese subjects.

Dr. Chris LU, Chairman and CEO of Laekna, indicated that Laekna plans to commence the phase I MAD study right after completing the SAD study in order to further evaluate the tolerability and efficacy to accelerate the clinical and business development of LAE102. “We will make every effort to bring this precision therapy to overweight and obesity patients who are in need of novel treatment options for achieving quality weight control”.

LAE102 is an internally discovered, first-in-class 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 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. Laekna announced, in November, 2024, a clinical collaboration with Lilly to support and accelerate global development of LAE102 for the treatment of obesity.

Laekna has established a comprehensive Activin-ActRII portfolio to maximize the value of targeting ActRII receptors. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual-target inhibitor targeting ActRIIA/IIB. Both of them are our internally discovered antibody and have progressed to IND-enabling studies. We will explore LAE123 as new treatments in life threatening diseases such as PAH, SMA, etc.

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IR  ir@laekna.com

Media  communication@laekna.com

Corporate and Business Development  BD@laekna.com

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 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.

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 cancer, metabolic diseases and liver fibrosis patients around the world.

As of June 30, 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. It has been shown in the pre-clinical studies to increase lean mass and decrease fat mass. 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.

Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experiences and deep know-how in this specific field and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of targeting ActRII receptors. 

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates, covering the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/ PD-L1 drug-resistant solid tumors. 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.

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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