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February 10, 2022 (shanghai, China)-Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced the publication of Phase II trial results of the investigational, novel, anti-IL-17A antibody vunakizumab in patients with moderate-to-severe plaque psoriasis in the Journal of the American Academy of Dermatology.

In this Phase II study, vunakizumab demonstrated superior efficacy in clearing skin lesions in all dosing groups and similar safety profile as compared with placebo.¹ The positive clinical results warranted further investigation of vunakizumab in larger and longer-term studies.¹

• There were significantly greater proportion of patients achieving at least 75% improvement in the psoriasis area and severity index (PASI 75) at week 12, which was the primary endpoint, in all vunakizumab groups compared with placebo (40, 80, 160, 240 mg: 56.8%, 65.8%, 81.6%, 86.5% vs. 5.4%; all P < 0.001);¹
• The 240 mg dosing regimen demonstrated the best clinical response at week 20, with PASI 75, PASI 90 and PASI 100 response rates of 97.3%, 75.7% and 45.9% respectively;¹
• Following the last drug administration at week 20, mean PASI response and the response rates of PASI 50, PASI 75, PASI 90 and PASI 100 were constantly higher in the vunakizumab groups than the placebo group through week 36;¹
• The most frequent adverse event (AE) was upper respiratory tract infection (vunakizumab, 16.7%; placebo, 16.2%). Most AEs were mild or moderate and none of the serious AEs were considered treatment-related by the investigators.¹

About Psoriasis

Psoriasis is an immune-mediated, chronic, inflammatory skin disorder. There are around 2-4% of the world population experiencing psoriasis.² Psoriasis is characterized by erythematous and scaly skin plaques, which can be painful, itchy or even disfiguring.³

About the study (SHR-1314-A201, NCT03463187, Part B)

SHR-1314-A201 is a Phase I/II, multi-center, randomized, double-blinded, placebo-controlled, dose-ranging study, in which 187 patients were enrolled from the United States, Australia and China. In Part B of the study, patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab 40, 80, 160, 240 mg or placebo subcutaneously every four weeks until week 12 (2 more drug administrations for the vunakizumab groups on week 16/20). The primary endpoint was the proportion of patients achieving PASI 75 at week 12. The study was to evaluate the efficacy and safety of vunakizumab as well as to determine its optimal dose to support further investigations in phase III studies.

About Vunakizumab

Vunakizumab (SHR-1314), a recombinant humanized monoclonal antibody against IL-17A, is being developed by Hengrui. Vunakizumab has a potential to bring dosing convenience to patients with fewer loading doses compared with the marketed anti-IL-17A antibodies. And it has demonstrated promising efficacy and good safety profile in patients with psoriasis and ankylosing spondylitis. Data of this published Phase II study were also presented at ACR Convergence 2020.⁴ Of note, even when administered without loading doses, vunakizumab (240 mg) achieved a 50% reduction in mean PASI score at week 2 in patients with moderate-to-severe plaque psoriasis, indicating its rapid onset of action despite less intensive loading dosing. Vunakizumab is currently 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).

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 24th among the top 1,000 global pharma companies in 2021.⁵ Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

1. Zhang C, Yan K, Diao Q, Guo Q, Jin H, Yang S, Chen X, Lei T, Wu J, Yu, H, Zheng M, Gao X, Sinclair R, Zhu Y, Xu Q, Xu J, A Multi-Center, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study Evaluating Efficacy and Safety of Vunakizumab in Patients with Moderate-to-Severe Plaque Psoriasis, Journal of the American Academy of Dermatology (2022), doi: https://doi.org/10.1016/j.jaad.2022.01.005.

2. Michalek IM, Loring B , John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol 2017;31:205-12.

3. Boehncke W-H , Sch?n MP. Psoriasis. The Lancet 2015;386:983-94.

4. https://acrabstracts.org/abstract/a-multi-center-randomized-double-blind-placebo-controlled-dose-ranging-study-evaluating-efficacy-and-safety-of-shr-1314-in-subjects-with-moderate-to-severe-plaque-psoriasis/

5. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.

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