ADA 2025 | Laekna Presented Clinical and Pre-clinical Studies Results of LAE102, LAE103 and LAE123

Laekna (2105.HK) announced today that the results of: i) the phase I SAD study of LAE102 (an ActRIIA-selective antibody) for the treatment of obesity; and ii) the pre-clinical study of LAE102, LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody) as therapeutics for muscle growth and fat reduction were presented at the 85^th scientific sessions of the American Diabetes Association (ADA).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250623952873/en/

ADA is one of the global leading conferences dedicated to diabetes research, care, and innovation and has taken place in Chicago, USA, from June 20 to 23 this year.

Professor Xuening LI, Zhongshan Hospital affiliated to Fudan University, Principal Investigator of the Phase I Clinical Trial of LAE102 in China

“The clinical research team at Zhongshan Hospital affiliated to Fudan University conducted the first-in-human study of LAE102 in a scientific, efficient, and rigorous manner. As the Principal Investigator of this trial, I am delighted to see this First-in-class research achievement being presented at the scientific sessions of the 2025 ADA. Based on the clinical data of LAE102 in overweight and obese populations, we endorse further clinical development of this innovative drug candidate.”

Professor Linong JI, Peking University People’s Hospital, Chairman of the Expert Advisory Committee of Laekna Overweight / Obesity Clinical Projects

“We continued to witness cutting-edge researches in metabolism and weight management leading the industry, with “China Innovation” demonstrating great potential and impact. Even more exciting is the emergence of novel pathways and targets like ActRII, which can be the next generation of high-quality weight-loss therapies following GLP-1. We congratulate the team on the positive data from the first-in-human study of LAE102 and look forward to more comprehensive and diverse data from its global study in the next phase, which may address current clinical challenges – including concurrent muscle loss during fat reduction – seen with existing therapies.”

Dr. Chris LU, Chairman and CEO of Laekna

“At the ADA Scientific Sessions, Laekna showcased LAE102, LAE103, and LAE123 – an innovative portfolio targeting the ActRII pathway – highlighting our team's extensive expertise and leadership in this field. We extend our deepest gratitude to the investigators, advisory experts, trial participants, and global clinical partners for their invaluable contributions.

As a pioneer in research and development of ActRII pathway, we are committed to collaborating with global partners to conduct extensive and in-depth investigations of this target. Through developing novel drug candidates and expanding therapeutic indications, we aim to fully unlock its potential to benefit patients with obesity, sarcopenia, and other severe diseases.”

Presentation details are as follows:

Poster No.1
Abstract Number: 2205-LB
Title: First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LAE102 in Healthy Volunteers

Highlights:

• A total of 40 participants were enrolled in Part A (IV) and 24 participants in Part B (SC). All participants completed the study as designed. The mean age was 29.0 years and 31.2 years, with the mean BMI 23.32 kg/m² and 23.08 kg/m² in Part A and Part B, respectively. Baseline demographic and clinical characteristics were generally balanced across the IV and SC cohorts of the study.
• Overall, LAE102 was well tolerated following a single IV or SC dose. No SAEs or TEAEs leading to discontinuation of treatment were reported. The majority of the TEAEs were mild laboratory test abnormalities, which were asymptomatic and did not require medical intervention. There was no reported case of diarrhea.
• Activin A was significantly increased in 24h following a single intravenous or subcutaneous dose of LAE102. The duration of Activin A elevation was dose-dependent. The high-dose groups (8 mg/kg IV group, 16 mg/kg IV group, and 8 mg/kg SC group) maintained 2-to-3-fold increases above the baseline level through 28 days post-administration, indicating prolonged pathway blocking.
• Conclusion: Single-dose administration of LAE102 by IV or SC injection demonstrated a favorable safety profile in the healthy participants. LAE102 exhibited apparent nonlinear clearance saturation at concentrations of approximately 2~4 μg/mL, a threshold that coincided with the sustained PD effect of LAE102, maintaining Activin A levels more than 2-fold above the baseline. The robust PK/PD correlation suggests potential efficacy and supports further clinical development of LAE102 in overweight and obese populations.

Poster No.2
Abstract Number: 861-P
Title: Targeting Activin Type II Receptors—Develop Monoclonal Antibodies LAE102, LAE103, and LAE123 as Candidate Therapeutics for Muscle Growth and Fat Reduction

Highlights:

• LAE102, LAE103, and LAE123 are high-affinity functional antagonists. They can completely inhibit the signaling transduced by ligands such as activin A, B, AB, and MSTN, all of which are known to contribute to muscle atrophy. In addition, they also inhibit activin E and GDF3, which promote lipid accumulation of adipose tissue.
• In mouse models, LAE102 alone significantly induced muscle growth and reduced fat mass, while LAE103 had less effect. Notably, a synergistic effect on muscle increase and fat loss was observed when combining LAE102 with LAE103, achieving the maximal effect comparable to the ActRIIA-IIB dual-specific antibody LAE123.
• Conclusion: The findings indicate that ActRIIA is a major regulator of muscle growth and fat loss in mice. LAE102 shows great potential as muscle preserving weight loss management with a favorable safety profile. On the other hand, LAE123 could be utilized to treat diseases requiring completely inhibition of both ActRIIA and ActRIIB, such as spinal muscle atrophy.

Laekna has established a comprehensive portfolio of targeting ActRII receptors and is progressing the clinical trials of LAE102 for the treatment of obesity in China and the US. Additionally, LAE103 and LAE123 have advanced to IND-enabling studies. Laekna is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250623952873/en/