Akeso, Inc. announced that its AK152, a novel bispecific antibody targeting both amyloid-beta (Aß) and blood-brain barrier (BBB) expressed receptor, has been granted approval by the National Medical Products Administration (NMPA) to initiate clinical trials for Alzheimer's Disease. AK152 is the first bispecific antibody developed in China for disease-modifying therapy in Alzheimer's Disease, marking a significant breakthrough in the field. Furthermore, it is Akeso's first innovative therapeutic candidate designed to target the central nervous system (CNS).
The receptor-binding arm of AK152 leverages the receptor-mediated endocytosis-transcytosis mechanism to significantly enhance the brain penetration of AK152. Preclinical studies have demonstrated that AK152 possesses robust bioactivity and a favorable profile. Compared to conventional monoclonal antibodies targeting Ab, AK152 significantly improves brain penetration, accelerating Ab plaques, and reverses the progression of Alzheimer's-related neuropathology in pre-clinical models, offering a potentially promising new treatment options for Alzheimer's patients.
CNS diseases have long posed significant therapeutic challenges on a global scale. Akeso, with its deep expertise in bispecific antibody development, is at the forefront of creating novel therapies to address critical unmet clinical needs in CNS diseases. On the Ab side, it not only binds to Ab plaques but also selectively targets the more neurotoxic soluble Ab oligomers.
On the BBB side, it leverages receptor-mediated endocytOS to significantly enhance brain penetration. Preclinical studies have shown that AK152 demonstrates strong bioactivity and a favorable safety profile, effectively increasing brain penetration, accelerating Ab pl plaque clearance, and exhibiting superior therapeutic efficacy over monoclonal antibodies in AD mouse models. These initial promising results suggest that AK152 has the potential to become a next-generation disease-modifying therapy for Alzheimer's disease.
