Phase II Clinical Trial of QX004N/HS-20137 for Psoriasis Shows Impressive Efficacy, Selected for Late-Breaking Oral Presentation at AAD 2025
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
March 9, 2025 17:07
This article is reprinted from:Hansoh Pharmaceutical Group Company Limited
- Over a 28-week treatment period, HS-20137 demonstrated robust efficacy and favorable safety in patients with moderate to severe plaque psoriasis.
To evaluate the efficacy, safety, and pharmacokinetic profile of HS-20137 in adult patients with moderate to severe plaque psoriasis, this study employed a randomized, double-blind, placebo-controlled trial design spanning 52 weeks. The trial included a 28-week double-blind treatment period (with the first 16 weeks being placebo-controlled), a 16-week open-label extension treatment period, and an 8-week follow-up period. Participants were randomly assigned to one of four groups: HS-20137 100mg Q8W, 200mg Q8W, 200mg Q12W, or placebo. The primary endpoint was the proportion of participants achieving PASI 90 at week 16. After week 16, the placebo group received the study drug at a dose of 200mg.
Research Results
This study enrolled a total of 159 subjects, with 156 subjects completing the primary endpoint assessment.
Key endpoint results are impressive:At Week 16, the achievement rates for PASI 75 and PASI 90 in the 200mg Q8W dose group were 92.3% and 76.9%, respectively (NRI imputation), and the rate for PASI 100 in the 200mg Q12W dose group reached 40%.。The proportion achieving PASI 90 further increased after 16 weeks, reaching up to 84.6%, 89.7%, and 87.2% at weeks 20, 24, and 28 respectively in the 200mg Q8W dose group.
Rapid onset from the first injection:HS-20137 takes effect rapidly, with PASI scores decreasing by over 40% from baseline after the first 4 weeks of treatment, over 70% reduction in PASI after 8 weeks, an average PASI below 3.3 at 16 weeks, followed by a continued steady decline, and an average value below 3.0 at 28 weeks.
Quality of Life Continues to Improve:The skin quality of life index of subjects improved significantly with treatment, and the mean DLQI score in the trial drug group was less than 5 points between weeks 16 and 28.
HS-20137 Injection is a recombinant humanized IgG1 monoclonal antibody that specifically binds to human IL-23, classified as a Class 1 innovative therapeutic biologic. HS-20137 works by specifically binding to the p19 subunit of human IL-23, blocking the interaction between extracellular IL-23 and the IL-23 receptor on the cell surface, and inhibiting the release of pro-inflammatory cytokines and chemokines mediated by IL-23, thereby achieving therapeutic effects for psoriasis.
The results of the Phase II study reported at this year's AAD conference further confirm the efficacy of HS-20137 in treating psoriasis, consistent with the findings published in JAMA Dermatology.JAMA Dermatology) are consistent with the Phase I study results[1]。
In April 2024, Hansoh Pharma entered into a strategic cooperation agreement with Quanxin Biotech, granting Hansoh Pharma exclusive rights for the research, development, production, and commercialization of all developable dosage forms and indications of HS-20137 Injection in China (including Hong Kong, Macao, and Taiwan).
In recent years, biologicsDoseDue toItsHasMoreA high benefit-risk ratio has become the main systemic medication recommended by clinical guidelines for treating psoriasis, playing a positive and effective role in the treatment of moderate to severe, refractory, and special types of psoriasis.[3,4]。
The annual meeting of the American Academy of Dermatology (AAD) is one of the largest, most influential, and representative international academic conferences in the field of dermatology. It attracts dermatology experts from all over the world each year, who share the latest research advancements in the field of dermatology, making a profound impact on the specialty.
Hansoh Pharma is a leading innovation-driven pharmaceutical company in China, with the mission of "Continuous Innovation for a Better Life". The company focuses on major therapeutic areas such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases. To date, Hansoh Pharma has launched 7 innovative drugs, building a robust product pipeline. The company has consistently ranked among the top 100 global pharmaceutical enterprises and within the top 3 of China's best industrial enterprises in pharmaceutical R&D for many years. It is also a key national high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (Stock Code: 03692.HK).
For more information, please visit: https://cn.hspharm.com/.
References:
[1]Li X., Li B., Yang D., et al. JAMA Dermatol. 2024;161(2):1-9.
[2].Vos T., Lim S. S., Abbafati C., et al. The Lancet. 2020;396(10258):1204–1222.
[3].Menter A., Strober B.E., Kaplan D.H., et al. J Am Acad Dermatol. 2019;80(4):1029-1072.
[4].Nast A., Smith C., Spuls P.I., et al. J Eur Acad Dermatol Venereol. 2020;34(11):2461-2498.
[5].Sbidian E., Chaimani A., Guelimi R., et al. Cochrane Database Syst Rev. 2023; 12;7(7):CD011535.
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