I’ve written about the “The Mystery of
Vobarilizumab (ALX-0061)” on this blog [1] and asked the question: “will the
phase 3 study really start? And when it starts, will vobarilizumab show a
significant reduction in radiographic progression.”
Clinical Trial lists six studies for Vobarilizumab
(ALX-0061) [2], one recruiting, another one still active, the others completed.
“Vobarilizumab is a Nanobody® consisting of
an anti-IL-6R domain and an anti-human serum albumin domain in development for
treatment of RA.” At the 2017 EULAR Annual Meeting Vobarilizumab has been
discussed in two studies.
T. Dörner and colleagues presented the
following study [3]: “REMISSION AND MAINTENANCE OF EFFICACY IN A PHASE 2B STUDY
OF VOBARILIZUMAB, AN ANTI-INTERLEUKIN 6 RECEPTOR NANOBODY, IN PATIENTS WITH
MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS DESPITE TREATMENT WITH METHOTREXATE”.
The authors concluded: “In patients with active RA, treatment with
vobarilizumab at the 3 highest dose regimens in addition to MTX had a positive
and sustained impact on disease activity through Week 24 as defined by
clinically relevant efficacy endpoints.”
And T. Dörner and colleagues presented a
second study [4]: “RESULTS OF A PHASE 2B STUDY OF VOBARILIZUMAB, AN
ANTI-INTERLEUKIN-6 RECEPTOR NANOBODY, AS MONOTHERAPY IN PATIENTS WITH MODERATE
TO SEVERE RHEUMATOID ARTHRITIS”. In this study the conclusions are: “In
patients with active RA, treatment with vobarilizumab monotherapy had a
positive impact on disease activity with no unexpected safety findings.” Tested
against tocilizumab, vobarilizumab fared well. The data puts tocilizumab at 162mg
q1w in between vobarilizumab at 150mg q2w and 225mg q2w.
The data is interesting and promising, but
the big question remains: will there be a phase 3 study? Ablynx didn’t mention a
phase 3 study up until today [4].
Links and
References:
[3] Annals of the Rheumatic Diseases, volume
76, supplement 2, year 2017, page 92 / Session: Progress in biological
treatment of RA , (Oral Presentations ) / DOI:
10.1136/annrheumdis-2017-eular.3732
.
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