Innovent Biologics Doses First Patient in Phase III Psoriasis Trial for Picankibart

Innovent Biologics Doses First Patient in Phase III Psoriasis Trial for Picankibart

China-based Innovent Biologics, Inc. (HKG: 1801) announced the first subject dosing in a Phase III clinical study for picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody. The trial aims to evaluate the efficacy and safety of picankibart in psoriasis patients who have not responded adequately to anti-IL-17 antibodies. The study is expected to enroll 310 subjects and includes a control group continuing to receive IL-17 inhibitors. The primary endpoint is the proportion of participants achieving a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.

Picankibart’s Promising Phase II Results
Picankibart (IBI112), a monoclonal antibody specifically targeting the IL-23p19 subunit, has demonstrated its ability to rapidly take effect and improve quality of life in patients with a poor response to previous treatments. In earlier Phase II trials, the drug showed significant promise in addressing unmet needs for patients with inadequate response to existing therapies.

Regulatory Progress in China
Picankibart is currently awaiting regulatory decisions in China for the treatment of moderate-to-severe plaque psoriasis. In September of last year, the National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for review, marking a significant step toward potential approval in the Chinese market.-Fineline Info & Tech