Innovent to seek Chinese approval for IL-23 psoriasis drug after phase 3 success

Innovent has reported positive results for its anti-IL-23 monoclonal antibody, picankibart, in treating moderate to severe plaque psoriasis. The phase 3 CLEAR-1 trial, which included 500 Chinese patients, demonstrated that picankibart effectively cleared skin and reduced the severity of the disease, setting the stage for potential regulatory approval in China.

The trial's primary and key secondary endpoints were met, with 80.3% of patients receiving picankibart achieving a 90% or greater improvement in their Psoriasis Area and Severity Index (PASI) score at 16 weeks, compared to only 2% in the placebo group. Additionally, a physician's assessment revealed that 93.5% of these patients had clear or almost-clear skin, compared to 13.1% in the placebo cohort.

Patients initially received a 200-mg injection of picankibart, followed by the same dose at weeks 4 and 8. They were then divided into two groups: one receiving 100-mg and the other 200-mg doses every 12 weeks. Innovent disclosed that the "strong efficacy" observed at Week 16 was maintained through Week 52 in both dose groups. Specifically, 84.9% of patients in the 200-mg group retained a PASI score of 90% or higher, while 85.9% maintained clear or almost-clear skin after one year.

Innovent emphasized the long-term efficacy of picankibart, stating that these results reinforce its potential as a robust treatment for moderate to severe psoriasis. Lei Qian, M.D., Ph.D., vice president of clinical development at Innovent, noted that the success of the CLEAR-1 trial supports picankibart's efficacy and safety as a new generation of IL-23p19-targeting drugs. Unlike some existing treatments, picankibart is designed for less frequent dosing, which could offer a more convenient option for patients.

In the U.S., the FDA has already approved several antibodies targeting the IL23p19 subunit, including Sun Pharma's Ilumya, Johnson & Johnson's Tremfya, and AbbVie's Skyrizi. Innovent aims to position picankibart as a competitive alternative with its extended half-life and less frequent dosing regimen.

The recent trial results will be used to support Innovent's application to Chinese regulators for picankibart's approval. Qian expressed confidence that the new treatment could offer a "more convenient, friendly, and effective regimen" for patients with moderate to severe plaque psoriasis.

In the broader context of psoriasis treatments, Johnson & Johnson is also developing an IL-23R antagonist peptide, JNJ-2113, in collaboration with Protagonist Therapeutics. Although this oral treatment did not meet the high benchmarks set by injectable alternatives in a phase 2 trial last year, its oral administration could offer significant convenience, prompting the companies to advance it to phase 3.

The successful trial of picankibart is part of a series of clinical achievements for Innovent this year. The company has also reported positive phase 3 results for its thyroid eye disease drug, a competitor to Amgen's Tepezza, and has shown promising outcomes for mazdutide, a GLP-1R/GCGR dual agonist licensed from Eli Lilly, in both diabetes and weight loss treatments.

In summary, Innovent's picankibart has demonstrated strong efficacy and safety in a phase 3 trial for moderate to severe plaque psoriasis, potentially offering a convenient and effective treatment option pending regulatory approval in China. This marks another significant milestone for Innovent as it continues to expand its clinical successes.