Akeso's AK139 IND Accepted: Bispecific Antibody for Respiratory and Skin Diseases

HONG KONG – February 13, 2025 – Akeso, Inc. has announced a significant milestone with the acceptance of its Investigational New Drug (IND) application by China's National Medical Products Administration for an innovative bispecific antibody, AK139. This development marks a pioneering step in the treatment of respiratory and skin diseases as AK139 becomes the first bispecific antibody targeting both IL-4Rα and ST2 to enter clinical trials.

AK139 is Akeso's seventh bispecific antibody to reach the clinical development stage and stands out as the company’s first non-oncology related bispecific antibody. The antibody offers a dual-target approach by simultaneously engaging the IL-4/IL-13 pathway and the IL-33/ST2 pathway, which are critical in the progression of various inflammatory diseases. These pathways are typically involved in the inflammatory mechanisms underpinning conditions such as asthma and chronic obstructive pulmonary disease (COPD).

Preclinical trials have showcased AK139's potential, demonstrating enhanced therapeutic effects over current single-target treatments. By blocking the IL-4Rα, AK139 interferes with the interaction between IL-4 and IL-13, two cytokines that contribute to immune responses mediated by T-helper 2 (Th2) cells. This action reduces the inflammation contributing to several respiratory and skin conditions. Concurrently, the antibody's binding to ST2 obstructs IL-33-driven inflammation, a significant factor in various inflammatory responses across multiple bodily systems.

Akeso's innovative dual-target approach aims to provide a new level of therapeutic efficacy by addressing the complexity of inflammation in related diseases. Evidence from preclinical evaluations has indicated that AK139 significantly surpasses the performance of existing therapies that target either IL-4 or ST2 individually. The antibody has shown remarkable synergy in reducing cytokine release and mitigating the infiltration of inflammatory cells in affected tissues, key indicators of its potential success in clinical application.

Moreover, the safety profile of AK139, as suggested by toxicology studies, remains favorable, further enhancing its promise as a breakthrough treatment option. The dual-target mechanism introduces what is anticipated to be a "dual-target era" in the management of diseases where these inflammatory pathways are pivotal.

This advancement comes as a welcome development for patients who have inadequate responses to existing therapies. AK139 is poised to offer enhanced therapeutic options, potentially transforming treatment paradigms for respiratory and dermatological conditions. The results from ongoing preclinical studies bolster the prospect that AK139 could represent a significant leap forward in addressing diseases driven by these complex inflammatory pathways.

As Akeso embarks on this new chapter, the introduction of AK139 into clinical development represents a promising horizon for interventions targeting intricate immune responses. This bispecific antibody not only reflects the company’s commitment to innovation outside the realm of oncology but also underscores the potential for novel therapeutic pathways to address unmet medical needs in inflammatory diseases.

In conclusion, AK139’s entry into clinical trials marks a significant step toward redefining treatment strategies and improving patient outcomes in conditions influenced by IL-4Rα and ST2 pathways. This progress signifies an exciting time for Akeso and offers hope for more effective treatments for complex inflammatory disorders.