ADA 2025 | Laekna Presented Clinical and Pre-clinical Studies Results of LAE102, LAE103 and LAE123
- Single-dose administration of LAE102 by IV or SC injection demonstrated a favorable safety profile in the healthy participants as well as robust and prolonged target engagement in the healthy participants
- Suggests a potential efficacy and supports further clinical development of LAE102 in overweight and obese populations
- Preclinical studies indicate that LAE102 alone significantly induced muscle growth and reduced fat mass. 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
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Laekna (2105.HK), a science-driven, clinical-stage biotechnology company, announced 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 85th scientific sessions of the
Professor
“The clinical research team at
Professor
“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.
“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
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
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
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
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.
For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/
Forward-Looking Statements
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Source: Laekna
