Akeso is adding a pair of late-stage wins to its scorecard in both ankylosing spondylitis and atopic dermatitis while also teeing up a new drug submission for one of the candidates.
The Hong Kong-based company said a trial assessing gumokimab met all efficacy endpoints in patients with active ankylosing spondylitis, a chronic inflammatory disease that mostly impacts the spine and sacroiliac joints.
The trial’s primary endpoint measured the percentage of participants who experienced a 20% improvement on an indication-specific scale at Week 16, according to ClinicalTrials.gov.
The study also met a secondary endpoint measuring ASAS40, which indicates a 40% improvement on the scale plus an absolute improvement across several symptoms.
The placebo-controlled, multisite trial run across China enrolled more than 500 people and was designed to evaluate the safety and efficacy of Akeso’s investigational drug, according to the U.S. database.
Akeso did not provide any data behind the announcement, sharing only that the investigational medicine “significantly improved disease activity and enhanced physical function and quality of life in patients,” according to an Aug. 25 release.
Gumokimab, also called AK111, is an anti-IL-17A monoclonal antibody that Akeso has already tested out in a separate phase 3 trial for moderate to severe psoriasis. In that trial, almost all patients achieved at least 75% improvement in disease area and severity at 12 weeks.
The pivotal psoriasis study prompted Akeso’s new drug application submission to Chinese regulators at the beginning of this year. The drug currently awaits an approval decision.
Beyond AK111, the biopharma also said its anti-IL-4Rα monoclonal antibody—known as manfidokimab or AK120—met all primary endpoints in a phase 3 study for moderate to severe atopic dermatitis.
The investigational asset “notably improved skin lesions” and provided early itch relief, according to Akeso.
The trial also hit several prespecified secondary endpoints, the biopharma said.
Based on the “strong efficacy and safety profile,” Akeso plans to file a new drug application for manfidokimab in the space, with hopes of delivering “a more effective and domestically developed IL-4Rα-targeting biologics” for atopic dermatitis patients in China.
The trial win supports Akeso’s effort to bolster its non-oncology portfolio and follows the commercial launches of cholesterol drug ebronucimab (PCSK9) and ebdarokimab for moderate to severe plaque psoriasis, both in China.
Akeso is largely known for its cancer collaboration with Summit Therapeutics centered on the PD-1xVEGF bispecific antibody ivonescimab.
In its first global phase 3 readout, ivonescimab reduced the risk of progression or death by 48% in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer and improved progression-free survival outcomes. The trial tested the addition of the drug to chemotherapy against chemotherapy alone.