QX002N / Qyuns Therap, Palisade Bio - LARVOL DELTA

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