Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe diseases.
LAE123’s Dual Inhibition of ActRIIA/IIB Signaling
LAE123 is an in-house developed monoclonal antibody that dually inhibits ActRIIA/IIB signaling, which is induced by their ligands, including Myostatin, Activins (such as Activin A, Activin B, Activin AB, Activin C, and Activin E), and Growth/differentiation factors (GDFs, such as GDF3 and GDF11). Dysregulation of ActRIIA/IIB signaling has been implicated in a variety of diseases, ranging from obesity and sarcopenia to other severe conditions. The potential of LAE123 to modulate this signaling pathway makes it a promising candidate for treatment in serious life-threatening diseases.
Targeting Severe and Life-Threatening Diseases
LAE123 will be tested in serious life-threatening diseases such as pulmonary arterial hypertension and spinal muscular atrophy. The initiation of the IND-enabling study is a crucial phase in the drug development process, aimed at gathering the necessary data to support the filing of an IND application with regulatory authorities, ultimately paving the way for clinical trials and potential patient access to this novel therapeutic.-Fineline Info & Tech
