Akeso’s monoclonal antibodies (mAbs) gumokimab and manfidokimab have met their primary endpoints during Phase III trials in ankylosing spondylitis (AS) and atopic dermatitis (AD).
During the study (NCT06378697) evaluating gumokimab (AK111) in AS, the drug was found to rapidly alleviate symptoms of the inflammatory condition, while enhancing physical function and patient quality of life.
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Gumokimab also bolstered ASAS20 scores in patients, triggering a 20% improvement in AS symptoms from baseline after the 61-week study period.
On top of its impact on ASAS20 scores, gumokimab offered statistically significant improvements to Assessment of Spondyloarthritis International Society 40 (ASAS40) scores in patients. To achieve a significant result, patients must experience a 40% improvement in three of four of the key domains from baseline – including disease activity, back pain, morning stiffness and physical function.
Though Hong Kong-based Akeso has not yet provided the full data from this study’s results, the company noted that gumokimab could be considered “an effective treatment option for AS” moving forward.
Akeso is currently seeking approval for the fully human mAb in China for psoriasis, with the National Medical Products Administration (NMPA) accepting a new drug application (NDA) for this indication in January 2025. However, the company has not yet revealed regulatory plans for gumokimab in AS indications.
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By GlobalDataManfidokimab scores in Phase III
Akeso’s manfidokimab, also a mAb, joined gumokimab in producing positive results this week. Manfidokimab (AK120) met all its primary and key secondary endpoints during a Phase III study in AD, according to the company during a concurrent announcement on both drugs.
Conducted across Australia and New Zealand, the trial (NCT04256174) revealed that manfidokimab could improve skin lesions and reduce itching in patients with the condition.
Akeso also noted that the drug “met several pre-specified secondary endpoints,” in a 25 August release, though the biopharma is yet to disclose the detailed results of this study.
Moving forward, the company plans to file for an NDA in China for manfidokimab in atopic dermatitis, which will “aim to provide a more effective and domestically developed IL-4Rα-targeting biologic for AD patients” in the country, the company said.
This decision comes at a time when the AD market is set for significant growth, with analysts at GlobalData predicting that the indication will be worth $22.4bn by 2033 across the seven major markets (7MM: United States, France, Germany, Italy, Spain, the UK and Japan).
GlobalData is the parent company of Clinical Trials Arena.
The reignited industry interest in this indication was primarily driven by the approval of Sanofi and Regeneron’s IL-4Rα-blocking mAb Dupixent (dupilumab) in 2017, which has since become one of the best-selling drugs in history.
Raking in $14.1bn in global sales in 2024, Dupixent’s revenue is only expected to increase to 2031, with GlobalData’s analysts predicting that it will generate $25.3bn.
However, the drug is now subject to notable competition in AD, as there are currently three other FDA-approved mAbs that are used to treat the indication, including Almirall and Eli Lilly’s Ebglyss (lebrikizumab), Leo Pharma’s Adtralza (tralokinumab), and Chugai Pharmaceutical’s Nemluvio (nemolizumab).
