LAE103 / 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

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

INVESTIGATIONAL NEW DRUG APPROVAL FOR LAE103 WAS OBTAINED FROM THE U.S. FOOD AND DRUG ADMINISTRATION (HKEXnews) - "Reference is made to the announcement of the Company dated June 30, 2025 in relation to the submission of an Investigational New Drug (the 'IND') application to the U.S. Food and Drug Administration (the 'U.S. FDA') for LAE103, an internally discovered monoclonal antibody against ActRIIB for the treatment of patients with sarcopenic obesity and other muscle related diseases. The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that the IND approval from the U.S. FDA has been obtained for LAE103 and the Company targets to bring this precision therapy to metabolic patients who are in need of novel treatment options."

IND • Obesity • Sarcopenia

Hong Kong Stocks Move | LaeKai Pharmaceuticals-B (02105) rose more than 4% again and submitted a new drug clinical trial application for LAE103 to the US FDA [Google translation] (Sina Corp) - "On the news front, Laekna Pharmaceuticals recently announced that the group has submitted a new drug clinical trial application (IND) to the U.S. Food and Drug Administration (FDA) for its independently developed LAE103 (a monoclonal antibody targeting ActRIIB), which may be used to treat patients with sarcopenia obesity and muscle-related diseases. The group plans to evaluate the efficacy and safety of monoclonal antibodies targeting ActRIIA and ActRIIB receptors in humans....Pacific Securities reported that both the domestic MAD study (subcutaneous administration) and the US Phase 1 of LAE102 have been initiated, and data are expected to be read out in 25H2. The Chinese Phase I MAD study of LAE102 has been initiated to evaluate the safety, tolerability, PD and PK of subcutaneous administration of LAE102 in 60 overweight/obese subjects, and data are expected to be read out in 25Q3."

IND • Obesity • Sarcopenia