LAE102 / Laekna Therap - LARVOL DELTA

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants (clinicaltrials.gov) - P1 | N=104 | Not yet recruiting | Sponsor: Laekna Limited

New P1 trial • Genetic Disorders • Obesity

Evaluate LAE102 in Healthy and Overweight/Obese Subjects (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Laekna Limited | Trial completion date: Feb 2026 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Obesity

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Laekna Limited | Active, not recruiting ➔ Completed

Trial completion

Voluntary Announcement | Preliminary Results from The Phase I MAD Study LAE102 Demonstrated Encouraging Trend Towards Lean Body Mass Increase and Fat Mass Reduction (Laekna Press Release) - "The LAE102 6 mg/kg group exhibited a 1.7% increase in mean lean body mass; And a 2.2% reduction in mean fat mass compared to the baseline; Adjusted from the placebo control group, the mean lean body mass is increased by 4.6%, whereas the mean fat mass is reduced by 3.6%....Consistent with the prior Phase I single ascending dose study ('SAD Study') of LAE102, the MAD Study demonstrated a well-tolerated safety profile, with no serious adverse events reported. Majority of TEAEs were mild (grade 1) and transient lab test abnormality. There was no diarrhea, muscle spasm or acne reported. The safety results were consistent with the known safety profile and no new safety signals were observed."

P1 data • Obesity

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Laekna Limited | Recruiting ➔ Active, not recruiting

Enrollment closed

Expected upcoming milestones in second half of 2025 (Laekna Press Release) - "About LAE102: Preliminary results of Phase I MAD Study in China; Preliminary results of U.S. Phase 1 Clinical Trial...Other Targeting ActRII Receptors: To initiate phase I clinical study of LAE103."

New P1 trial • P1 data • Obesity

ADA 2025 | Laekna Presented…Pre-clinical Studies Results of LAE102, LAE103 and LAE123 (Businesswire) - "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..."

Preclinical • Muscular Atrophy

First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LAE102 in Healthy Volunteers (ADA 2025) - "A single dose of LAE102 IV or SC demonstrated a favorable safety profile in healthy participants. Robust PK/PD correlation indicate potential efficacy and support clinical development of LAE102 SC in overweight and obese population.$$Figure. Mean LAE102 Serum Concentration and Percentage Change of Mean Serum Activin A Levels from Baseline after SC Administration."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Metabolic Disorders • Obesity • ACVR2A

Targeting Activin Type II Receptors—Develop Monoclonal Antibodies LAE102, LAE103, and LAE123 as Candidate Therapeutics for Muscle Growth and Fat Reduction (ADA 2025) - "The findings indicate that ActRIIA is a major regulator of muscle growth and fat loss. 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."

Metabolic Disorders • Obesity • ACVR2A • TGFB1

Laika Pharmaceuticals: LAE102, standing on the shoulders of giants [Google translation] (Sohu.com) - P1 | N=124 | NCT06493084 | Sponsor: Laekna Limited | "In the Phase I SAD study, 64 healthy subjects with an average BMI of 23.2 kg/m² were treated with LAE102. The results showed that all subjects tolerated the single dose of LAE102 well, no serious adverse events were reported, and no study discontinuation due to adverse events occurred. No obvious gastrointestinal adverse events were observed, and no diarrhea occurred. A strong PK/PD correlation was observed, indicating that there was strong target inhibition at low doses."

P1 data • Obesity

[Tianfeng Pharmaceuticals Yang Song Team | First Coverage] Laika Pharmaceuticals: Targeting the emerging track of weight loss and muscle gain, LAE102 has a promising future [Google translation] (Sina Corp) - P1 | N=124 | NCT06493084 | Sponsor: Laekna Limited | "The SAD study data of LAE102 showed encouraging safety and tolerability characteristics. A total of 64 patients were included in the study, and the results showed that no serious adverse events occurred and no treatment was discontinued due to adverse events. All treatment-related adverse events reported so far have been well tolerated, most of which were reported as mild (grade 1) laboratory abnormalities without any clinical symptoms or signs. No cases of diarrhea were reported. The trial observed significant drug-target engagement and expected changes in pharmacodynamic biomarkers, and a single dose of LAE102 resulted in a significant and sustained increase in activin A levels, indicating strong target inhibition. The duration of target inhibition was related to the dose level."

P1 data • Obesity

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Laekna Limited | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Laekna Limited

New P1 trial

Evaluate LAE102 in Healthy and Overweight/Obese Subjects (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Laekna Limited | N=72 ➔ 124 | Trial completion date: Jun 2025 ➔ Feb 2026 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Enrollment change • Trial completion date • Trial primary completion date • Obesity

Announcement | Submission of IND Amendment to U.S. FDA for LAE102 for the Treatment of Obesity (Laekna Press Release) - "This announcement is made by Laekna, Inc. (the ‘Company', together with its subsidiaries, the ‘Group') on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business update of the Group. The board (the ‘Board’) of directors of the Company (the ‘Directors’) is pleased to announce that the Group has submitted an Investigational New Drug (‘IND’) amendment to the U.S. Food and Drug Administration (the ‘U.S. FDA’) for LAE102 for the treatment of obesity....The U.S. Phase 1 Clinical Trial is expected to commence in the second quarter of 2025."

FDA event • New P1 trial • Obesity

Laekna Announced Completion of a Successful Phase I SAD Study of LAE102 for the Treatment of Obesity (Laekna Press Release) - "Laekna, Inc...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 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....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."

New trial • P1 data • Trial completion • Metabolic Disorders • Obesity

Laekna Announces a Clinical Collaboration with Lilly to Develop LAE102, a Novel Monoclonal Antibody Targeting Activin Receptor Type 2A for The Treatment of Obesity (Businesswire) - "Laekna, Inc...is pleased to announce a clinical collaboration with Eli Lilly and Company (Lilly), a global leader in cardiometabolic health, including diabetes and obesity, to accelerate the development of LAE102, a novel ActRIIA mAb as a novel treatment for obesity....Clinical development of LAE102 through phase 1 study including obese patients; Lilly will fund, share resources and expertise to accelerate research and development timelines; Laekna retains global rights for LAE102..."

Licensing / partnership • Metabolic Disorders • Obesity

Evaluate LAE102 in Healthy Subjects and Subjects with Overweight Obesity (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Laekna Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Evaluate LAE102 in Healthy Subjects and Subjects With Overweight Obesity (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Laekna Limited

New P1 trial • Genetic Disorders • Obesity

Laekna announces first IND clearance by U.S. FDA for internally-discovered LAE102 (PRNewswire) - "Laekna...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of LAE102 antibody to initiate clinical development....The drug candidate is now cleared for a phase I/II study targeting solid tumors, with the indication of Non-Small Cell Lung Cancer (NSCLC)."

IND • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer