October 28, 2024-Akeso Biopharma (9926.HK) released comprehensive data from its pivotal Phase 3 study (AK111-301) evaluating gumokimab (AK111), a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds and neutralizes IL-17A, for the treatment of moderate to severe plaque psoriasis. This study was conducted in China and achieved its primary endpoint in 2023. The study has recently been completed with promising long-term efficacy and safety results.
The findings indicate that gumokimab offers superior treatment outcomes for patients with moderate to severe plaque psoriasis, showing sustained improvement and durable results. This therapy aligns with patients' clinical objectives for achieving complete clearance of skin lesions and maintaining disease stability without exacerbation.
- Rapid Onset of Action: Based on the Phase 3 clinical study of gumokimab, after 2 weeks of treatment with gumokimab, the average percentage change in PASI exceeded 40% compared to baseline. At week 4, over 50% of participants achieved a PASI75 response, and at week 8, more than 85% achieved a PASI75 response.
- Sustained Improvement:By week 52, the PASI75 response rate approached 100%, with an sPGA 0/1 response rate of approximately 90%, a PASI90 response rate exceeding 90%, and a PASI100 response rate greater than 70%.
- Long-lasting Maintenance:8 weeks after discontinuation of treatment, approximately 97% of the participants maintained their PASI75 and sPGA 0/1 responses compared to week 52.
The incidence rate of adverse events with gumokimab treatment for moderate to severe plaque psoriasis is comparable to that of the placebo group, demonstrating good safety and tolerability.
AK111-301 is a randomized, double-blind, placebo-controlled multicenter Phase 3 study conducted in patients with moderate to severe plaque psoriasis, with a treatment follow-up of 56 weeks.
AK111-301 study reached its primary endpoint in 2023. The efficacy results at 12 weeks showed:
- The PASI75 response rate for gumokimab treatment exceeded 90% (primary endpoint), with an sPGA 0/1 response rate approaching 90% (co-primary endpoint).
- As research and treatment for psoriasis advance, more participants anticipate maximal improvement in their skin lesions: at week 12, over 80% of participants achieved a PASI90 response, and approximately 50% achieved a PASI100 response.
