Innovent Biologics’ challenger to drugs including Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi has cleared phase 2. The study found the anti-IL-23 monoclonal antibody, which is designed to be given less frequently than some rivals, outperformed placebo in terms of reducing psoriasis area and severity.
China-based Innovent is developing picankibart, also known as IBI112, to provide patients with an IL-23 drug that has an extended half-life. In the U.S., the FDA has already approved antibodies against the IL23p19 subunit, with Sun Pharma’s Ilumya joining Tremfya and Skyrizi among the authorized products, but Innovent sees value in developing an extended half-life treatment that can be dosed less frequently.
Having designed its molecule, Innovent began a Chinese phase 2 clinical trial of the candidate last year. The study randomized 250 people with moderate-to-severe plaque psoriasis to receive placebo or one of four subcutaneous dose regimens of IBI112.
After 16 weeks, 52.0% to 54.9% of subjects in the IBI112 cohorts had experienced PASI 90, defined as a 90% or greater improvement on an index of psoriasis area and severity. The result caused the trial to hit its primary endpoint. Innovent also reported significant improvements in PASI 75 and 100 versus placebo and continued rises in the rate of PASI 90, which hit the 61.2% to 72.5% range by week 28.
The PASI 90 rate at week 16 is lower than those achieved by Tremfya and Skyrizi in the clinical trials that supported their approvals in the U.S. Tremfya came to market after achieving PASI 90 rates of 70% and 73% at week 16 in two phase 3 clinical trials. The Skyrizi approval was underpinned by a pair of phase 3 trials in which 75% of participants on the study drug experienced PASI 90.
Most participants in the IBI112 arms received two doses four weeks apart and then subsequent doses every 12 weeks, meaning they had only had two shots at the time of the primary endpoint analysis. One of the IBI112 arms used an eight-week dosing interval after the two initial shots. The 12-week schedule is less onerous than that of Tremfya, which is given every eight weeks, but the same as that of Skyrizi.
China approved imports of Tremfya in 2019. Skyrizi is approved for the treatment of plaque psoriasis in the U.S., Canada, Mexico, Japan and the European Union. Innovent is working to bring IBI112 to market in China. A phase 3 clinical trial is planned.