- LAE103 is an ActRIIB selective antibody, another internally discovered drug candidate targeting the ActRII pathway , in addition to LAE102(an ActRIIA-selective antibody)

- The company plans to separately evaluate the efficacy and safety of monoclonal antibodies targeting against ActRIIA and ActRIIB in humans 

June XX, 2025 — Laekna (2105.HK) announced today that the company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for LAE103, an internally discovered monoclonal antibody against ActRIIB for the treatment of patients with sarcopenic obesity and muscle related disease.

LAE103 is another key asset in our innovative ActRII portfolio, in addition to LAE102, an ActRIIA-selective antibody. Laekna will work closely with the regulatory authorities to complete the application and targets to bring this precision therapy to metabolic patients who are in need of novel treatment options.

The company plans to separately evaluate the efficacy and safety of monoclonal antibodies targeting against ActRIIA and ActRIIB in humans.

At the latest 85th scientific sessions of the American Diabetes Association, Laekna presented clinical and pre-clinical results of the three drug candidate assets of it’ s innovative ActRII portfolio.

- LAE102 (an ActRIIA-selective antibody), demonstrated a favorable safety profile as well as robust and prolonged target engagement in its first-in-human study. Laekna is progressing the Phase I clinical trials of LAE102 for the treatment of obesity in China and the U.S.

- LAE103 (an ActRIIB-selective antibody), IND application has been submitted to the FDA

- LAE123 (an ActRIIA/IIB dual antagonistic antibody), has advanced to IND-enabling studies

About LAE103

LAE103 is an ActRIIB selective antibody. Laekna is actively advancing this drug candidate to clinical studies as novel therapies for sarcopenic obesity and muscle related disease.

About Sarcopenic obesity

Sarcopenic obesity is a chronic disease characterized by the simultaneous presence of decreased skeletal muscle mass and function, alongside an excessive accumulation of adipose tissue. This dual condition poses significant health risks, particularly in older adults, as it is linked to increased frailty, cardiovascular diseases, fractures, and higher mortality rates. The global prevalence of sarcopenic obesity among adults is rising rapidly, driven by demographic shifts and lifestyle changes.

The multifactorial etiology of sarcopenic obesity may involve aging, inappropriate lifestyle (sedentary, improper diet, lack of exercise), inflammation, and comorbidities of acute and chronic diseases.

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Contact Us

IR  ir@laekna.com

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/

Forward-Looking Statements

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.