The 33rd Annual Congress of the European Academy of Dermatology and Venereology (EADV 2024) was held in Amsterdam from September 25 to 28, 2024. The Phase II clinical trial data for Hansoh Pharma 's HS-10374 on plaque psoriasis were presented at the congress in the form of an oral presentation.
The EADV Congress is Europe’s largest international meeting focused on dermatology and venereology, providing a platform for researchers, clinicians, and industry professionals to exchange knowledge, network, and present their latest research findings.
HS-10374 is a novel, highly selective, allosteric tyrosine kinase 2 (TYK2) inhibitor developed by Hansoh Pharma. As TYK2 is essential for signaling of interleukin (IL)-12 and IL-23, which are key cytokines involved in psoriasis pathogenesis, HS-10374 was expected to offer therapeutic benefit in the treatment of psoriasis.
The recently published clinical trial results of HS-10374 showed significant clinical efficacy versus PBO in terms of PASI 75 response rate and sPGA 0/1 response rate with oral doses of ≥6 mg in patients with moderate-to-severe plaque psoriasis. The overall safety profile was similar to other TYK2 inhibitors but showed less risk of skin toxicity. Trials with a longer treatment duration and larger populations are required to further confirm the efficacy and safety of HS-10374 in such patients.
Study profile
Title: Efficacy and Safety of HS-10374 in Patients with Moderate-to-Severe Plaque Psoriasis: Results from A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Trial
Format: Oral presentation
Session code and title: D3T01.4 Late breaking news
Presentation time: September 27th, 2024, 16:00 (CEST)/22:00 (CST)
Abstract N°: 7722
Corresponding author: Jinhua Xu，Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
First author: Ling Han，Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
Presenter: Yan Zhou，Department of Dermatology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, China.
Methods:
In this phase 2, randomized, double-blind, placebo-controlled trial (NCT06077331), 125 patients with moderate-to-severe plaque psoriasis were randomized 1:1:1 to receive HS-10374 6 mg, 12 mg or placebo (PBO) orally once daily (QD). The treatment period was 12 weeks, followed by a 4-week follow-up period for safety monitoring.
Results:
Efficacy (data at Week 12): The primary endpoint was met, with a significantly greater proportion of patients in HS-10374 6 mg and 12 mg groups achieving PASI 75 responses compared with PBO (PBO: 7.5%; HS-10374 6 mg: 28.6%, P=0.013; HS-10374 12 mg: 72.1%, P<0.001). Significantly greater proportion of patients in HS-10374 6 mg and 12 mg groups achieved sPGA 0/1 responses compared with PBO as well (PBO: 10.0%; HS-10374 6 mg: 33.3%, P<0.05; HS-10374 12 mg: 65.1%, P<0.001).
Safety: AE rates of HS-10374 groups were slightly higher than PBO group (PBO: 70.0%; HS-10374 6 mg: 76.2%, HS-10374 12 mg: 88.4%), while rates of treatment-related AEs (TRAEs), serious AEs (SAEs), and AEs leading to discontinuation of trial regimen were comparable across the three treatment groups, and the only patient with treatment-related SAE was from PBO group. The overall safety profile of HS-10374 was similar to other TYK2 inhibitors. In contrast to the relative higher incidence of skin-related adverse events for some other TYK2 inhibitors, AEs under “skin and subcutaneous disorders” in this study were more commonly reported in PBO group. Treatment with HS-10374 did not result in significant changes from baseline in mean values of laboratory parameters.
Conclusion:
Based on these Phase 2 results, Hansoh will initiate a Phase 3 study of HS-10374 in moderate-to-severe plaque psoriasis this year to further confirm the efficacy and safety of HS-10374.
