Akeso Biopharma (HKG: 9926), based in China, has announced that its pivotal Phase III clinical trial for the interleukin (IL)-17A monoclonal antibody (mAb) AK111 in moderate to severe plaque psoriasis has successfully met all primary efficacy endpoints, including PASI100 and sPGA0/1.
This randomized, double-blind, placebo-controlled, multi-center study was designed to evaluate the efficacy and safety of AK111 in patients suffering from moderate to severe plaque psoriasis. Results indicated that all dosing groups of AK111 significantly improved patient outcomes compared to the control group, with notable increases in the proportion of patients achieving PASI 75, sPGA 0/1, PASI 90, and PASI 100, while maintaining a favorable safety profile. After 12 weeks of treatment, AK111 not only enhanced skin lesions but also substantially improved patients’ quality of life.
In addition to psoriasis, AK111 is being developed for ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA). Competing products, such as Novartis’ Cosentyx (secukinumab) and Eli Lilly’s Taltz (ixekizumab), are already available in China, generating sales of USD 4.7 billion and USD 2.4 billion, respectively, in 2022. AK111’s strong efficacy and safety profile position it as a competitive contender in this lucrative market.- Flcube.com
