Ablynx initiates the second of two Phase IIb rheumatoid arthritis studies with ALX-0061
Posted: 7 April 2015 |
Ablynx has announced the start of a Phase IIb study to evaluate the efficacy and safety of ALX-0061 as a treatment for rheumatoid arthritis…
Ablynx has 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 (sc) as a monotherapy in adult patients with active rheumatoid arthritis (RA) who are intolerant to methotrexate (MTX) or for whom MTX is inappropriate.
The study also aims to obtain parallel descriptive information concerning the efficacy and safety of administration of sc tocilizumab (Actemra® RoActemra®) in the same RA population.
InSeptember 2013, Ablynx and AbbVie entered into a global license agreement worth up to US$840 million 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 first Phase IIb study with ALX-0061 in combination with MTX in patients with active RA started on17 March 2015.
This current Phase IIb study is a multi-centre randomised study consisting of two parallel treatment groups: a double-blind part to assess the efficacy and safety of ALX-0061 sc and an open-label part (with a blinded independent joint-assessor) with tocilizumab sc which is not used as an active comparator but to provide parallel efficacy and safety data for sc tocilizumab in the same RA patient population.
The study is expected to enrol 228 subjects in the U.S., Europe and South America who will be randomly assigned to three different dose groups of ALX-0061 sc or one dose group of tocilizumab sc. Administration of ALX-0061 will be performed every 2 weeks or every 4 weeks for 12 weeks. Subjects will be followed for efficacy up to week 12 and for safety until 12 weeks after last dosing. Following completion of the 12-week dosing eligible subjects will be invited to participate in an open-label extension study.
Top line results from the Phase IIb studies of ALX-0061 are expected before the end of 2016
The primary endpoint is the ACR20 response of ALX-0061 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 of ALX-0061 documentation of efficacy of ALX-0061 over time as well as 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 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 commercialisation.”
For more information about Ablynx, please visit www.ablynx.com.
