Ablynx has administered the first dose in the Phase II STEADY study to evaluate the efficacy and safety of its anti-IL-6R Nanobody, ALX-0061, administered subcutaneously in adult patients with moderate to severe, active seropositive SLE, despite receiving the standard-of-care.
The study also 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 $840 million plus double-digit royalties, to develop and commercialize ALX-0061. As part of the agreement, Ablynx is responsible for Phase II clinical development of ALX-0061 in rheumatoid arthritis and systemic lupus erythematosus.
This Phase II study in SLE is a multi-centre, randomized, double-blind, placebo-controlled, dose-range finding study. It is expected to enrol approximately 300 subjects in the United States, Europe, South America and Asia, who will be randomly assigned a placebo or one of the four different dose groups of ALX 0061. Subjects will be followed for efficacy up to and including week 48 and for safety up to and including week 58.
The study’s primary endpoint is the percentage of subjects who achieved a response at week 24 according to the composite BICLA score (BILAG-based Combined Lupus Assessment). This is a broadly accepted, sensitive, clinically meaningful composite measure of SLE disease activity that requires disease improvement across all body systems with moderate or severe baseline activity without concurrent worsening in other body systems or increase in background medication.
The secondary endpoints include the composite systemic lupus erythematosus responder index (SRI), the individual components of the composite endpoints, as well the effects of ALX-0061 on health-related quality of life, flare rate and use of corticosteroids. 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 patients suffering from debilitating inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus. The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018. If the results meet the pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent development and commercialisation.”