Innovent Biologics has announced that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. This marks a significant step forward in addressing the needs of Chinese patients suffering from this chronic skin condition.
Picankibart is the first IL-23p19 antibody drug to demonstrate that over 80% of subjects achieved PASI 90 after 16 weeks of treatment in a registrational Phase 3 clinical trial. Furthermore, it offers a long maintenance dosing interval, administered once every 12 weeks, setting it apart from other biologics in the same class. The drug is poised to provide comprehensive benefits to patients, including significant skin lesion clearance, improved medication convenience, and an enhanced quality of life.
CLEAR-1 Phase 3 Trial Results
The NDA acceptance is grounded in the positive outcomes of the Phase 3 registrational clinical study CLEAR-1 (NCT05645627), conducted in Chinese patients with moderate to severe plaque psoriasis. The study met its primary and all key secondary endpoints in May 2024, revealing significantly higher rates of skin lesion clearance, as measured by PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0, in the picankibart group compared to the placebo group. The picankibart group also demonstrated a notable improvement in quality of life, as indicated by DLQI 0/1 scores. Importantly, picankibart exhibited a favorable safety profile, with no new safety signals detected during the trial.
Professor Yulin Shi, the principal investigator of the clinical study from Shanghai Skin Disease Hospital, emphasized the impact of psoriasis on patients' physical and mental well-being. "Selecting effective treatment options is essential for managing the condition, reducing comorbidities, sustaining long-term therapeutic benefits, and improving overall quality of life," said Professor Shi. "Evidence indicates that IL-23p19-targeted antibodies offer advantages in maintaining long-term efficacy and treatment convenience, which Picankibart has clearly demonstrated in clinical trials."
Psoriasis Treatment Landscape
Psoriasis is a chronic, recurrent, inflammatory, and systemic disease influenced by both genetic and environmental factors. It affects individuals across all age groups and genders, typically manifesting as scaly erythema or plaques. Approximately 80% to 90% of patients have plaque psoriasis, with nearly 30% of these cases classified as moderate to severe. In China alone, over 7 million people are affected by psoriasis. Current systemic treatments include methotrexate (MTX), cyclosporine A, retinoic acids, and biological agents. Since 2019, biologics, particularly IL-23 inhibitors, have become a central focus in psoriasis treatment due to their rapid onset, robust efficacy, good safety profile, and long-lasting effects.
Innovent's Broader Pipeline
Dr. Lei Qian, Vice President of Clinical Development of Innovent, highlighted the significance of this regulatory milestone. "This marks the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA in China," said Dr. Qian. "Considering its efficacy, safety, and long-interval maintenance dosing, picankibart demonstrates best-in-class potential."
Innovent is actively expanding its innovative portfolio in ophthalmology, autoimmune diseases, and cardiovascular and metabolic (CVM) conditions, aiming to provide more patients with access to high-quality medicines. Multiple clinical studies of Picankibart are currently underway, including Phase 3 studies in plaque psoriasis, a Phase 2 study in patients previously treated with biologics, and a Phase 2 study in ulcerative colitis.
