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news.Ablynx has unveiled positive top-line results from a phase 2b clinical trial evaluating vobarilizumab (ALX-0061) in 251 patients with moderately to severely active rheumatoid arthritis (RA) who are intolerant to methotrexate or for whom methotrexate is inappropriate.
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The study’s objective was to investigate the safety and efficacy of several dose regimens for vobarilizumab monotherapy to support additional clinical development.
Its primary endpoint was the proportion of subjects achieving ACR20 (20% improvement in RA symptoms) at week 12.
Patients were randomized to receive one of three subcutaneous regimens of vobarilizumab (150 mg every four weeks, 150 mg every two weeks or 225 mg every two weeks) or open-label tocilizumab (Roche’s Actemra) every one or two weeks (the comparator drug).
Subjects in the vobarilizumab 225 mg (n=63) responded the best with 81% achieving ACR20, 49% ACR50 and 21% ACR70.
The corresponding results in the tocilizumab arm were 78%, 45% and 23%.
Ablynx CMO Robert Zeldin said: The goal of RA treatment is to improve the signs and symptoms of the disease, reduce disease activity, induce remission, and improve physical function.
"We believe the data clearly demonstrate the potential of vobarilizumab as an important new treatment option for patients suffering from RA. We look forward to reporting the data from the methotrexate combination therapy study in RA later this quarter."
Vobarilizumab targets the interleukin 6 pathway through its IL-6 receptor (IL-6R). It is comprised of an anti-IL-6R Nanobody linked to an anti-human serum albumin Nanobody which increases the half-life of the molecule.