– A total of 64 healthy subjects with an average BMI of 23.2±2.2 kg/m2 enrolled into the SAD Study, including 5 intravenous cohorts and 3 subcutaneous cohorts

– The SAD Study data demonstrated an encouraging safety and tolerability profile, with no reported case of diarrhea or serious adverse events

– Obvious target engagements and expected pharmacodynamic biomarker changes have been observed. Single doses of LAE102 resulted in significant and sustained increases in activin A level, indicating robust target engagement

– Positive outcomes established a solid foundation for coming MAD Study in China and Phase I study in collaboration with Lilly in the U.S.

January 13, 2025 — Laekna, Inc. (2105.HK) (“Laekna”) today announced that the Group has successfully completed the phase I single ascending dose study (the “SAD Study”) of LAE102 for the treatment of obesity.

The SAD Study enrolled a total of 64 healthy subjects with an average BMI of 23.2±2.2 kg/m2, including 5 intravenous cohorts and 3 subcutaneous cohorts. The positive outcomes of the SAD Study results have established a solid foundation for the coming phase I multiple ascending dose study (the “MAD Study”) in China as well as the phase I clinical study in collaboration with Eli Lilly & Company (“Lilly”) in the U.S..

The SAD Study data of LAE102 analyzed to date demonstrated an encouraging safety and tolerability profile, with no serious adverse events and no discontinuations due to adverse events. All treatment emergent adverse events reported to date were very well tolerated, with the majority of them being reported as mild (grade 1) lab test abnormality without any clinical symptoms or signs. There is no reported case of diarrhea. Obvious target engagements and expected pharmacodynamic biomarker changes have been observed. Single doses of LAE102 resulted in significant and sustained increasing in activin A level, indicating a robust target engagement. The duration of target engagement correlated to the dose level. The detailed study results will be presented in a scientific conference as soon as possible.

The positive SAD Study results support continuing the investigation of LAE102 for the treatment of obesity. The Group plans to initiate the MAD Study in the first quarter of 2025 and to work closely with Lilly to commence the phase I clinical study in U.S. as soon as possible. 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. The Group aims to bring this precision therapy to overweight and obese patients who are in need of novel treatment options for achieving quality weight control.

"We are excited to have new clinical data with LAE102. The SAD result demonstrated the potential of selective Activin A receptor inhibition as an important therapeutic approach," said Dr. Chris Lu, Chairman and Chief Executive Officer of Laekna. "The dedication of all principal investigators and subjects are much appreciated. We are committed to accelerating the global development of LAE102 and making a meaningful impact on the lives of millions of people affected by obesity."

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. Laekna announced, in November, 2024, a clinical collaboration with Lilly to support and accelerate global development of LAE102 for the treatment of obesity.

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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 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/

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