Akeso Advances AK139 Bispecific Antibody into Phase II Trials
Akeso, Inc. (9926.HK) has received approval from China’s National Medical Products Administration (NMPA) to begin Phase II clinical trials for AK139, a first-in-class IL-4Rα/ST2 bispecific antibody. The trials will evaluate AK139 across seven indications, including chronic obstructive pulmonary disease (COPD), severe asthma, chronic spontaneous urticaria, allergic rhinitis, chronic rhinosinusitis with nasal polyps, moderate-to-severe atopic dermatitis, and prurigo nodularis.
This milestone highlights Akeso’s commitment to developing innovative therapies for respiratory and autoimmune diseases. Moreover, the approval positions AK139 as a promising candidate with the potential to address significant unmet clinical needs worldwide.
What Makes AK139 a Breakthrough Therapy?
AK139 is a clinical-stage bispecific antibody discovered through Akeso’s proprietary AI-enabled drug discovery platform. Notably, it expands the company’s expertise in bispecific and multispecific antibodies beyond oncology into major therapeutic areas such as immunology.
Chronic inflammatory diseases driven by the IL-4Rα/ST2 pathway often involve complex biological mechanisms and create a substantial patient burden. However, many patients experience limited symptom control with existing single-target therapies. Therefore, dual-target treatments like AK139 could transform disease management.
Dual-Target Mechanism Supports Strong Clinical Potential
As the world’s first antibody targeting both IL-4Rα and IL-33/ST2 pathways, AK139 blocks two key drivers of inflammation simultaneously. Specifically, it inhibits the IL-4/IL-13 signaling pathway while also suppressing IL-33/ST2-mediated inflammation.
Early research demonstrates strong bispecific binding affinity along with favorable pharmacological activity in both in vitro and in vivo studies. In addition, AK139 has shown improved efficacy in reducing inflammatory cytokine release and tissue inflammation compared to single-target antibodies. Previous studies also indicate a positive safety profile.
Expanding Innovation in Autoimmune Treatment
Currently, no approved therapy targets both pathways together. Consequently, AK139 could usher in a “dual-target era” for treating respiratory, autoimmune, and dermatological conditions.
The advancement of AK139 further strengthens Akeso’s growing autoimmune pipeline, which includes therapies such as ebdarokimab (IL-12/IL-23), gumokimab (IL-17A), and manfidokimab (IL-4R). Together, these innovations reinforce the company’s strategy to deliver next-generation treatments that improve patient outcomes.
Forward-Looking Statement
This announcement contains forward-looking statements that reflect Akeso’s current expectations and involve risks and uncertainties. Actual results may differ due to regulatory, economic, competitive, and technological factors. Drug candidates mentioned may not obtain approval or achieve commercial success. Akeso assumes no obligation to update these statements unless required by law.
