Ablynx, a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, recently announced the administration of the first dose in a Phase IIb clinical trial that is evaluating the safety and efficacy of their anti-IL-6R Nanobody®, ALX-0061 for the treatment of patients with Rheumatoid Arthritis (RA) who cannot cope with methotrexate (MTX). The trial is also aiming to obtain details about the safety and efficacy for the same group of patients of tocilizumab sc (Actemra®, RoActemra®).
Abbvie and Ablynx have been collaborating since September 2013 in a partnership that is worth about US $840 million plus double-digit rights, for the development and commercialization of ALX-0061. As part of this partnership, Ablynx is evaluating in a Phase II study the efficacy and safety of ALX-0061 for the treatment of patients with RA and systemic lupus erythematosus (SLE). The first Phase IIb trial of ALX-0061 plus MTX in patients for patients with active RA began on March 17th.
This Phase IIb trial is a randomized multicentre investigation that is testing the combination treatment in two study groups: a double-blind part that is evaluating the safety and efficacy of ALX-0061 sc, and a second part that is an open-label with tocilizumab sc, that is being used to provide information about the safety and efficacy for sc tocilizumab in the same RA patients.
The companies are expecting to enroll a total of 228 patients in South America, Europe and in the United States. Patients will be assigned at random into three ALX-0061 sc dose groups or in one tocilizumab sc dose group. Patients will receive the drug for 12 weeks, every 2 or 4 weeks. The efficacy will be assessed up to week 12 and safety will be assessed until 12 weeks following last dosing. After the 12 weeks, eligible patients will be asked to take part in an open-label extension study.
The primary study outcome is to assess the ACR20 response of ALX-0061 after 12 weeks, a measure to determine the reduction in RA signs and symptoms. The secondary study outcomes involve higher level of response evaluations of ALX-0061, documentation of its efficacy over time, effects on the improvement in health-related quality of life and physical function. Other planned evaluations involve the determination of ALX-0061 levels, immunogenicity, safety, biomarkers and tolerability.
Dr. Edwin Moses, CEO of Ablynx, commented in a recent press release “Ablynx and our partner AbbVie are committed to developing ALX-0061 for people living with rheumatoid arthritis. The start of this second Phase IIb study in this chronic and progressive disease is therefore another important milestone. We expect top line results from the two Phase IIb studies in RA before the end of 2016. If the results meet pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialization.”