Core Viewpoint - Innovent Biologics announced promising results from a Phase 2 clinical study of picankibart, an IL-23p19 antibody, showing robust efficacy and a favorable safety profile in patients with plaque psoriasis who had inadequate responses to previous biologic treatments [1][2][5]. Clinical Study Results - The study involved 152 patients who switched from other biologics to picankibart, with 64.6% of patients achieving skin clearance or near clearance after 16 weeks of treatment [2][3]. - The primary endpoint was met with nearly half (48.2%) of patients with prior inadequate responses achieving an sPGA score of 0 or 1 and BSA of <3% [5]. - Secondary endpoints showed that 64.6% of patients with baseline sPGA of ≥2 and BSA of ≥3% achieved sPGA of 0 or 1 [5]. Patient Demographics - Among the 152 enrolled patients, 54.6% were classified as inadequate responders, with a median disease duration of 12 years [4]. - A significant majority (96.4%) of these patients had previously been treated with IL-17 inhibitors [4]. Safety Profile - The safety profile of picankibart was favorable, comparable to other studies, with no new safety signals identified [6]. - Long-term follow-up is ongoing to assess the full data on efficacy and safety [6]. Future Developments - Innovent plans to advance the Phase 3 clinical trial of picankibart, which is currently under review for a New Drug Application (NDA) by the NMPA [7][9]. - The company aims to address unmet clinical needs in psoriasis treatment and provide more options for patients with inadequate responses to existing biologics [7][9]. About Psoriasis - Psoriasis is a chronic inflammatory disease affecting a significant portion of the population, with over 7 million patients in China alone [8]. - Biologics have become the primary systemic treatment for moderate to severe psoriasis, with IL-23 inhibitors showing rapid onset and robust efficacy [8]. About Picankibart - Picankibart (IBI112) is a monoclonal antibody developed by Innovent, targeting the IL-23p19 subunit, with potential applications in treating psoriasis and other autoimmune diseases [9]. - Multiple clinical studies are ongoing, including a Phase 3 study for moderate to severe plaque psoriasis, which has already met its endpoints [9]. About Innovent - Innovent is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, having launched 11 products and with several new drug applications under regulatory review [10][11].
Innovent Announces Results of a Phase 2 Study of Picankibart (Anti-IL-23p19 Antibody) in Plaque Psoriasis, Showing Efficacy in Patients with Prior Inadequate Response to IL-17 Biologics