2021-08-25
NMPA IND clearance to initiate a Phase II study of vunakizumab for active psoriatic arthritis
China, 19th August 2021 - Hengrui Pharma announced that the Investigational New Drug (IND) application for vunakizumab (SHR-1314), a humanized monoclonal antibody targeting interleukin (IL)-17A, has been approved by the China National Medical Products Administration (NMPA) to conduct a Phase II clinical trial in adult patients with active psoriatic arthritis.
About SHR-1314
Vunakizumab (SHR-1314), a recombinant humanized monoclonal antibody against IL-17A, is being developed by Hengrui with rapid onset of action. Vunakizumab has a potential to bring dosing convenience with fewer loading doses compared with the marketed anti-IL-17A antibodies. Vunakizumab is being investigated in two registrational clinical trials: a Phase III clinical trial for psoriasis (NCT04839016) and a Phase II/III clinical trial for ankylosing spondylitis (NCT04840485). In a global Phase I/II clinical trial (NCT03463187), significantly higher PASI 75 response rates were observed in all vunakizumab (SHR-1314) dose cohorts compared with the placebo group at week 12 (p-values <0.001) in the moderate-to-severe plaque psoriasis patients1. Of note, in the 240 mg vunakizumab cohort, patients achieved a 50% reduction in mean PASI score at week 2, demonstrating a rapid onset of action despite less intensive loading dosing.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic immune-mediated inflammatory disease with multiple manifestations driving patient symptoms. There are approximately 125 million psoriasis patients worldwide (2% to 3% of world population), and approximately 30% of which develop arthritis. Psoriatic arthritis affects up to 50 million people worldwide2. Symptoms of psoriatic arthritis include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of tendons, and irreversible joint damage.