Ablynx announced that it has administered the first dose in the Phase IIb study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously in combination with methotrexate (MTX) in adult patients with active RA, despite MTX therapy. The study aims to identify the optimum dose and frequency of administration of ALX-0061 for the next phases of development.
Ablynx announced that it has administered the first dose in the Phase IIb study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously in combination with methotrexate (MTX) in adult patients with active RA, despite MTX therapy. The study aims to identify the optimum dose and frequency of administration of ALX-0061 for the next phases of development.
In September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061. As part of the agreement, Ablynx is responsible for Phase II clinical development of ALX-0061 in both RA and systemic lupus erythematosus (SLE).
The current Phase IIb study is a multi-centre, randomised, double-blind, placebo-controlled dose-range finding study of ALX-0061, administered subcutaneously in combination with MTX (a commonly used first-line DMARD (1) agent for patients with RA), in subjects with moderate to severe RA, despite MTX therapy. The study is expected to enrol 330 subjects in the United States, Europe and South America, who will be randomly assigned to placebo or four different dose groups of ALX-0061 administered subcutaneously. Administration will be performed every two weeks or every four weeks. Subjects will be followed for efficacy up to and including week 24 and for safety up to and including week 34. Following completion of the 24-week study, eligible subjects will be invited to participate in an open-label extension study.
The primary endpoint is the ACR20 response (2) at week 12, a broadly accepted clinical response measure to demonstrate reduction in RA signs and symptoms. The secondary endpoints include higher level of response assessments, documentation of efficacy of ALX-0061 over time, as well as of the effects of ALX-0061 on the improvement in physical function and health-related quality of life. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
Dr Edwin Moses, CEO of Ablynx, commented:
“Ablynx and our partner AbbVie are committed to making ALX-0061 available for people living with rheumatoid arthritis. The start of this first Phase IIb study in this chronic and progressive disease is therefore an important milestone. The programme is progressing according to plan and we expect top line results from the study before the end of 2016. If the results meet pre-defined success criteria, AbbVie will exercise its right to in-licence ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation.”
References:
- DMARD: disease modifying anti-rheumatic drug
- ACR (American College of Rheumatology) responses measure improvements in tender and swollen joint counts and improvements in three of five other disease-activity measures. To achieve an ACR20 the patients must show an improvement of at least 20%.
