The board (the ‘‘Board’’) of directors of the Company (the ‘‘Directors’’) is pleased to announce positive preliminary results from the Phase I multiple ascending dose study (the ‘‘MAD Study’’) of LAE102 for the treatment of obesity in China.
LAE102 (an ActRIIA-selective antibody), demonstrated a favorable safety profile as well as robust and prolonged target engagement in its first-in-human study.
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
The Phase I SAD study of LAE102 in China for the treatment of obesity has been completed, during which single doses of LAE102 resulted in significant and sustained increase in activin A level, indicating a robust target engagement.
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 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.
April 15, 2024 — Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration has approved the IND for LAE102, an internally discovered monoclonal antibody against ActRIIA, for the treatment of patients with obesity indication.
Laekna (2105.HK) announced that the company has submitted the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for LAE102, an internally discovered monoclonal antibody against ActRIIA, for the treatment of adult patients with obesity or metabolic diseases.
Laekna (2105.HK) announced that the Centre for Drug Evaluation of the National Medical Products Administration of China has accepted the Investigational New Drug application (IND) for LAE102, a potent, selective and internally discovered monoclonal antibody against ActRIIA, for the treatment of adult patients with obesity or metabolic diseases.