New hope for asthma and eczema? Akeso’s latest antibody AK139 enters clinical trials

Akeso, Inc. (9926.HK) has announced a major milestone with the acceptance of its Investigational New Drug (IND) application for AK139 by the China National Medical Products Administration (NMPA). AK139, a bispecific antibody therapy, is designed to target IL-4Rα and ST2, key pathways involved in chronic respiratory disease treatment and skin condition therapy. This development marks Akeso’s expansion beyond oncology, with AK139 representing its seventh bispecific antibody to enter clinical trials.

As the first-in-class bispecific antibody to address these dual pathways, AK139 has the potential to significantly improve treatment outcomes for patients suffering from inflammatory diseases, particularly those unresponsive to conventional monotherapy. Preclinical data suggest that blocking both the IL-4/IL-13 and IL-33/ST2 inflammatory pathways offers a synergistic therapeutic advantage, positioning AK139 as a promising innovation in respiratory disease treatment and skin condition therapy.

How Does AK139’s Dual-Target Mechanism Improve Treatment Outcomes?

Inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis are driven by dysregulated immune responses. While current therapies primarily target a single inflammatory pathway, AK139 introduces a bispecific antibody therapy approach, simultaneously neutralizing IL-4Rα and ST2 to disrupt key inflammatory processes.

IL-4 and IL-13 play a pivotal role in Th2-driven inflammation, which is implicated in various chronic conditions. By binding to IL-4Rα, AK139 effectively inhibits these cytokines, preventing excessive immune activation that contributes to respiratory disease treatment resistance. Meanwhile, IL-33, a critical alarm molecule, interacts with ST2 to amplify inflammatory responses. Elevated IL-33 and ST2 levels have been observed in severe cases of asthma and eczema, reinforcing the need for therapies that address both pathways simultaneously. AK139’s dual-target mechanism disrupts these inflammatory signals, potentially offering improved efficacy over existing monotherapies.

What Do Preclinical Studies Reveal About AK139’s Therapeutic Potential?

Preclinical research has provided strong evidence supporting AK139’s efficacy. Studies indicate that the bispecific antibody therapy demonstrates superior pharmacological effects compared to single-target IL-4Rα or ST2 inhibitors. AK139 has shown a greater reduction in inflammatory cytokine release and a significant decrease in immune cell infiltration, key indicators of disease progression in both respiratory disease treatment and skin condition therapy.

Beyond its efficacy, AK139 has also exhibited a favorable safety profile in preclinical toxicology assessments. The antibody’s specificity for IL-4Rα and ST2 reduces the likelihood of off-target effects, addressing a major concern associated with many immunomodulatory treatments. These promising findings pave the way for clinical trials aimed at validating its potential as a first-in-class therapy for patients who have not responded adequately to existing treatments.

Why Is AK139 Considered a First-in-Class Therapy?

The approval of AK139 for clinical trials represents a significant advancement in the field of bispecific antibody therapy. Unlike conventional biologics that target only one inflammatory pathway, AK139’s ability to inhibit both IL-4Rα and ST2 introduces a “dual-target era” in respiratory disease treatment and skin condition therapy. This innovative mechanism could lead to enhanced treatment responses in conditions where inflammation remains a primary driver of disease pathology.

As the first bispecific antibody to enter clinical development for these indications, AK139 holds the potential to redefine the standard of care. The therapy is particularly promising for patients with severe or treatment-resistant inflammatory diseases, offering new hope where existing treatments have shown limited success. The upcoming clinical trials will be crucial in determining whether this bispecific antibody therapy can establish a new benchmark in inflammatory disease treatment.

What Is Akeso’s Broader Strategy in Bispecific Antibody Development?

The IND acceptance of AK139 aligns with Akeso’s broader mission to innovate within the field of bispecific antibody therapy. The company has been actively advancing novel immunotherapies, as evidenced by its ongoing pivotal Phase III trial (HARMONi-6) evaluating ivonescimab, a bispecific PD-1/VEGF antibody for squamous non-small cell lung cancer (sq-NSCLC). This trial compares ivonescimab to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy.

With AK139, Akeso is demonstrating its ability to expand the application of bispecific antibody therapy beyond oncology and into inflammatory diseases. The company’s strategic focus on dual-target biologics underscores its commitment to addressing complex diseases with high unmet medical needs.

What’s Next for AK139 in Clinical Development?

Following its IND approval, AK139 is set to advance into early-phase clinical trials, where its safety, efficacy, and pharmacokinetics will be rigorously evaluated. The outcomes of these trials will determine its potential to enter later-stage development and, ultimately, secure regulatory approvals for broad patient use.

As research progresses, the industry will closely watch how AK139 performs in clinical settings. If its preclinical advantages translate into patient benefits, the therapy could become a game-changer in respiratory disease treatment and skin condition therapy. Akeso’s continued innovation in bispecific antibody therapy reinforces its position as a leader in next-generation biologics aimed at transforming treatment paradigms for inflammatory diseases.