Innovent to take IL-23 psoriasis drug to Chinese regulators after phase 3 win

Innovent’s psoriasis contender to IL-23 drugs like Tremfya and Skyrizi cleared skin and improved the severity of disease in a phase 3 test, setting up the company to seek approval from Chinese regulators.

The anti-IL-23 monoclonal antibody, called picankibart, hit all primary and key secondary endpoints in the late-stage CLEAR-1 trial of 500 Chinese patients with moderate to severe plaque psoriasis. Specifically, 80.3% of patients who received picankibart achieved a 90% or greater improvement in their Psoriasis Area and Severity Index (PASI) score at 16 weeks compared to just 2% of participants who received placebo.

A physician’s assessment at the same point—the other primary endpoint of the trial—produced similar results, with 93.5% of patients achieving clear or almost-clear skin compared to 13.1% of the placebo cohort.

Patients who received picankibart started with a 200-mg injection and then received the same dose again at weeks 4 and 8 before being split into those who received either a 100-mg or 200-mg dose every 12 weeks.

The “strong efficacy” was maintained through Week 52 in both of the picankibart cohorts, said Innovent, although yearlong data were only shared for the 200-mg group. Of these patients, 84.9% still had a PASI score of 90% or above at this point, while 85.9% maintained their clear or almost-clear skin.

“These results underpin the long-term robust efficacy of picankibart in treating moderate to severe psoriasis,” the biotech said in the May 27 release.

Picankibart is designed to be given less frequently than some rivals. While the FDA has already approved antibodies in the U.S. against the IL23p19 subunit—with Sun Pharma’s Ilumya joining Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi among the authorized products—Innovent sees value in developing an extended half-life treatment that can be dosed less frequently.

“Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart's outstanding efficacy and favorable safety as a new generation of IL-23p19 target drugs,” said Lei Qian, M.D., Ph.D., vice president of clinical development at Innovent.

Innovent will use yesterday’s results ­to prepare an application to Chinese regulators to approve picankibart as a “more convenient, friendly and effective treatment regimen for patients with moderate to severe plaque psoriasis,” Qian said.

J&J has another IL-23 psoriasis option in the works courtesy of an IL-23R antagonist peptide called JNJ-2113. The Protagonist Therapeutics-partnered candidate fell short of the high bar set by injectable treatments in a phase 2 trial last year, but the convenience of oral delivery means the companies have still pushed the asset into phase 3.

The picankibart results mark the latest in a string of clinical wins for Innovent this year. A thyroid eye disease rival to Amgen’s Tepezza hit its phase 3 endpoints, while the GLP-1R/GCGR dual agonist mazdutide licensed from Eli Lilly has demonstrated success in both diabetes and weight loss.