Disease Domain | Count |
---|---|
Immune System Diseases | 9 |
Infectious Diseases | 2 |
Neoplasms | 1 |
Top 5 Drug Type | Count |
---|---|
Monoclonal antibody | 10 |
Biological products | 3 |
Biosimilar | 2 |
Target |
Mechanism IL-17A inhibitors |
Active Org. Qyuns Therapeutics Co., Ltd.Startup |
Originator Org. Qyuns Therapeutics Co., Ltd.Startup |
Active Indication |
Inactive Indication |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target |
Mechanism IL-4Rα inhibitors |
Active Org. Qyuns Therapeutics Co., Ltd.Startup |
Originator Org. Qyuns Therapeutics Co., Ltd.Startup |
Active Indication |
Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target |
Mechanism IL-23p19 inhibitors |
Active Org. Qyuns Therapeutics Co., Ltd.Startup |
Originator Org. Qyuns Therapeutics Co., Ltd.Startup |
Active Indication |
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Start Date18 Jul 2024 |
Sponsor / Collaborator Qyuns Therapeutics Co., Ltd.Startup |
Start Date14 Jun 2024 |
Sponsor / Collaborator Qyuns Therapeutics Co., Ltd.Startup |
Start Date06 Jun 2024 |
Sponsor / Collaborator Qyuns Therapeutics Co., Ltd.Startup |
Objectives To investigate the safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an interleukin-17A monoclonal antibody, in Chinese patients with active ankylosing spondylitis (AS). Methods In this phase 1b, double-blind, placebo-controlled, multiple ascending dose study, eligible patients with active AS were randomized into three dose (40, 80, or 160 mg) cohorts, with a 4:1 ratio in each cohort to subcutaneously receive either QX002N or a placebo once every 2 weeks with six doses in total. All patients were followed for 14 weeks (98 days) after the last dose. The primary endpoints were the safety and pharmacokinetics of QX002N, and the secondary endpoints included its preliminary efficacy, pharmacodynamics, and immunogenicity. Results Thirty patients (n = 10 in each cohort) were included, with 24 receiving QX002N and 6 receiving a placebo. A total of 85 adverse drug reactions, predominantly Grade 1–2, were identified in 20 out of 24 patients (83.3%) who took QX002N. The exposure to QX002N increased proportionally with the dose escalating from 40 mg to 160 mg. Patients taking 160 mg QX002N achieved higher response rates (ASAS20: 87.6% at Week 8 [Day 56]); ASAS40: 50.0% at Week 12 [Day 78]), than those taking 40-mg or 80-mg QX002N. An increase in interleukin-17A and a decrease in interleukin-6 levels in the serum, with decreases in the erythrocyte sedimentation rate and high-sensitivity C-reactive protein levels, were observed. Anti-drug antibodies were detected in only one of 24 patients taking QX002N. Conclusions Subcutaneous administration of QX002N demonstrates a favorable safety profile, with linear PK characteristics. Promising clinical responses in pharmacodynamics and preliminary efficacy have been observed. Immunogenicity does not appear to be a concern. Trial Registration This study was registered with Chinadrugtrials.org.cn (CTR20201277)
Drug(Targets) | Indications | Global Highest Phase |
---|---|---|
Ustekinumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd) ( IL-12 x IL-23 ) | Plaque psoriasis More | NDA/BLA |
QX-005N ( IL-4Rα ) | Dermatitis, Atopic More | Phase 3 |
QX002N ( IL-17A ) | Ankylosing Spondylitis More | Phase 3 |
Tocilizumab Biosimilar(Jiangsu Quanxin Biomedical Co Ltd) ( IL-6RA ) | Rheumatoid Arthritis More | Phase 2 |
QX-004N ( IL-23p19 ) | Plaque psoriasis More | Phase 2 |