crusekitug (QX002N) / Qyuns Therap, Palisade Bio - LARVOL DELTA

Qyuns Therapeutics’ Ankylosing Spondylitis Drug Crusekitug Wins NDA Acceptance in China (TipRanks) - "The filing is supported by a Phase III trial showing significant and sustained improvements in disease activity and symptoms, including in patients previously treated with tumor necrosis factor inhibitors, along with favorable safety over 52 weeks and objective imaging evidence of reduced spinal and sacroiliac inflammation."

China filing • Ankylosing Spondylitis

Effect of QX002N on Clinical and Radiographic Outcomes in Ankylosing Spondylitis: Results from a Phase III Randomized, Double-blind, Placebo-Controlled Study (ACR Convergence 2025) - "QX002N provided significant improvements in the symptoms and signs, as well as marked reduction in inflammation of the spinal and SIJ as measured by MRI in r-axSpA patients, when compared to placebo at week 16. The safety of QX002N was tolerable."

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

CRUSEKITUG (QX002N) PHASE III CLINICAL TRIAL RESULTS FOR ANKYLOSING SPONDYLITIS PRESENTED AT THE 2025 ACR ANNUAL MEETING (HKEXnews) - "The results showed that at week 16, the ASAS40 response rate in the Crusekitug group was 40.4%, significantly higher than the 18.9% in the placebo group (P < 0.0001); meanwhile, the ASAS20 response rate in the Crusekitug group was 65.2%, also significantly higher than that in the placebo group (P < 0.0001), indicating that Crusekitug effectively alleviates the symptoms and signs of AS patients across multiple dimensions, including pain and spinal function."

P3 data • Ankylosing Spondylitis

Safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an anti-IL-17A monoclonal antibody, after short-term treatment of active ankylosing spondylitis. (PubMed, BMC Pharmacol Toxicol) - "Subcutaneous administration of QX002N demonstrates a favorable safety profile, with linear pharmacokinetic characteristics. Promising clinical responses in pharmacodynamics and preliminary efficacy have been observed. Immunogenicity does not appear to be a concern."

Journal • PK/PD data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL17A • IL6

PHASE III CLINICAL TRIAL OF QX002N FOR ANKYLOSING SPONDYLITIS REACHES PRIMARY ENDPOINT (HKEXnews) - P3 | N=640 | ChiCTR2300075284 | "The data showed that QX002N exhibited excellent efficacy as well as good safety and tolerance in patients with moderate-to-severe active ankylosing spondylitis....A total of 641 subjects with moderate-to-severe active ankylosing spondylitis were enrolled in the study, including 322 in the QX002N group and 319 in the placebo group....The ASAS40 response rate at week 16 in the treatment group receiving 160 mg of QX002N administered every four weeks (Q4W) was 40.4%, which was significantly higher than the 18.9% in the placebo group (P < 0.0001)....There was a significant difference in the ASAS20 response rate between the two groups at week 16 (65.2% QX002N vs. 41.3% placebo; P < 0.0001)."

P3 data • Ankylosing Spondylitis

Pharmacokinetics, Safety, and Immunogenicity of Intravenous and Subcutaneous Single-Dose QX002N Injection in Healthy Subjects: A Randomized, Open, Parallel, Single-Center, Phase I Study. (PubMed, Rheumatol Ther) - "Immunogenicity was assessed and all the subjects in this study were Anti-drug antibody (ADA)-negative, which means no subjects appeared to develop immunogenicity to QX002N. All the results testify to the safety of QX002N injection, which is satisfactory after IV or SC dosing in healthy subjects."

Journal • P1 data • PK/PD data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of the QX002N anti-IL-17 Monoclonal Antibody: A Phase I, Randomized, Double-Blind, Single Ascending Dose Study in Healthy Chinese Volunteers. (PubMed, Front Pharmacol) - "Based on the PKs and safety results of QX002N, 80 mg is recommended as the effective dose for a future phase Ib study. Clinical Trial Registration: https://www.chinadrugtrials.org.cn/, identifier ChiCTR1900023040."

Clinical • Journal • PK/PD data • Ankylosing Spondylitis • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatology • Seronegative Spondyloarthropathies • IL17A