MEDI 5117 / WuXi AppTec, AstraZeneca - LARVOL DELTA

Safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WBP216, a novel IL-6 monoclonal antibody, in patients with rheumatoid arthritis: A phase Ia randomized placebo-controlled study. (PubMed, Front Immunol) - "WBP216 is a novel human immunoglobulin G1 (IgG1) monoclonal antibody for interleukin (IL)-6. WBP216 demonstrated a good safety profile and evidence of potential efficacy in the treatment of patients with RA. http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml, identifier CTR20170306."

Journal • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Modeling and Simulation to Support Phase Ib/IIa Dose Selection for WBP216, A Long Half-Life Fully Human Monoclonal Antibody Against Interleukin-6. (PubMed, Front Pharmacol) - "We hope this first PK/PD study of WBP216 in Chinese RA patients will help in the clinical development of WBP216 in future and provide a reference to the dosage optimization of similar antibodies with long half-life. Clinical Trial Registration: CTR20170306."

Journal • P1/2 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6

AstraZeneca: Pipeline update (AstraZeneca Press Release) - Discontinuation of MEDI5117 for OA pain due to safety/efficacy reasons.

Discontinued • Immunology

Investigational New Drug Application for WuXi MedImmune's monoclonal antibody accepted for review by CFDA (PRNewswire) - "WuXi PharmaTech...announced today that an Investigational New Drug (IND) application for WuXi MedImmune's novel anti-IL6 monoclonal antibody for rheumatoid arthritis has been accepted for review by the China Food and Drug Administration (CFDA)." 

Non-US regulatory • Immunology • Rheumatoid Arthritis

Novel anti-IL-6 antibody for rheumatoid arthritis from WuXi-MedImmune joint venture receives clinical trial permit (CTP) from CFDA (PRNewswire) - "WuXi AppTec...and MedImmune...announced today that an Investigational New Drug (IND) application for WBP216 (MEDI5117)...has been approved by the China Food and Drug Administration (CFDA) as a class I biologic to enter Phase 1 clinical trials in China."

Licensing / partnership • New P1 trial • Non-US regulatory • Immunology • Rheumatoid Arthritis