Biopharmaceutical company Innovent Biologics, Inc. (HKEX: 01801) announced on Monday the latest clinical outcome of a Phase two study (ClinicalTrials.gov, NCT05970978) of picankibart (R&D code: IBI112), intended for the treatment of patients with plaque psoriasis that previously had an inadequate response to other biologics.
The multicentre, open-label Phase two study is evaluating picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, which has indicated robust efficacy and a favourable safety profile. The study enrolled 152 patients, earlier treated with marketed biologics for plaque psoriasis, which includes IL-17 inhibitors and TNF- alpha inhibitors. The study's primary endpoint was the proportion of patients achieving an sPGA score of zero or one and BSA of less than 3% at week 16.
This is the first clinical study in China assessing a switch from other biologics to an IL-23p19-targeted drug. It indicated that after 16-weeks of treatment with picankibart, most patients (64.6%,42/65) who had inadequate response to earlier biologic agents (mainly those targeting IL-17), achieved skin clearance or near clearance with a sPGA of zero or one. Results from this study are to provide evidence for novel long-term treatment regimens for patients with moderate to severe psoriasis. The company is to advance to a Phase three clinical trial of picankibart.
Professor Furen Zhang, the principal investigator for the Clinical Study, Dermatology Hospital Affiliated to Shandong First Medical University, said, 'Psoriasis is a chronic condition that significantly affects patients' physical and mental well-being and quality of life. Biologics have become the primary systemic treatment for moderate-to-severe, refractory, and special types of psoriasis. Despite their significant efficacy, a considerable proportion of patients still experience inadequate response during biologic therapy, necessitating the development of alternative treatments. I am pleased to see that picankibart has demonstrated favourable efficacy and safety in psoriasis patients with an inadequate response to prior biologic treatments, suggesting that picankibart could be a potential switching option. I look forward to confirming picankibart's benefits in the upcoming Phase 3 study, which could help more psoriasis patients.'
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