Akeso, Inc.  is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Administration (NMPA) for AK139, a bispecific antibody targeting IL-4Rα and ST2. AK139 is under investigation for a number of indications, including respiratory and skin diseases.

AK139 is Akeso's first innovative bispecific antibody outside the field of oncology to enter clinical development.  It is also Akeso's seventh bispecific antibody to enter clinical development. As the world's first IL-4Rα/ST2 bispecific antibody to enter the clinic, AK139 simultaneously targets and blocks both the IL-4/IL-13 pathway (by binding to the IL-4Rα subunit shared by both IL-4 and IL-13 receptor complexes) and the IL-33/ST2-mediated inflammation pathway. Preclinical studies have demonstrated robust synergistic therapeutic effects between these targets. In preclinical studies, AK139 shows clinical potential compared to existing monotherapy drugs targeting these pathways.  AK139 is expected to advance the treatment of respiratory diseases, dermatological conditions, and other disorders where these inflammatory pathways play a critical role in disease pathogenesis. This first in class therapy is set to introduce a "dual-target era" in the treatment of these conditions, providing enhanced therapeutic options for patients with inadequate responses to current treatments.