Hong Kong-based company Akeso has announced positive results in two phase III clinical trials of its antibodies Gumokimab and Manfidokimab for Ankylosing Spondylitis (AS) and Atopic Dermatitis (AD) respectively.
Gumokimab for Ankylosing Spondylitis
Gumokimab, targeting IL-17, was found to meet all its primary endpoints. In the announcement released by Akeso, the antibody demonstrated “both statistically significant and clinically meaningful improvements, further supporting the potential of gumokimab as an effective treatment option for AS.”
AS, a form of arthritis characterised by inflammation of the spine, is a long term condition with few effective treatment options beside pain relief and TNF inhibitors. The disease currently effects an estimated 4 million people in China.
The release continued: “Gumokimab rapidly and effectively alleviated AS symptoms, significantly improved disease activity and enhanced physical function and quality of life in patients.”
The drug has previously seen success in the clinic for psoriasis where the acceptance of its NDA made it Akeso’s third non-oncology drug to enter the market approval process.
Manfidokimab for Atopic Dermatitis
Manfidokimab, targeting IL-4Rα, also reported positive outcomes at Phase III, also meeting all primary endpoints as well as key secondary endpoints. The company said that the drug “demonstrated statistically significant and clinically relevant improvements in patients.”
Atopic dermatitis is a common form of eczma which causes skin discomfort and itching. Akeso announced that manfidokimab was able to notably improve skin lesions and provide relief from itching. The company says that their antibody could potentially transform the lives of patients with the condition.
Akeso say that they are now planning to file an NDA for manfidokimab due to the strong safety and efficacy profile of the therapy. This will make it the company’s fourth non-oncology drug to enter the NDA phase, bolstering Akeso’s autoimmune portfolio.
