Lately I have been contacted by one of my readers, what I
think of Vobarilizumab. Ups, I hadn’t heard so far about vobarilizumab, but I
had already written something on the compound – ALX-0061 (see links below).
Nice to know, that it had been named in the meantime.
Ablynx had published data on phase 2 studies. I had been
surprised as I hadn’t seen this data before. Last published data is of 2014:
EULAR
Abstracts:
[FRI0329] IMPACT OF CLINICAL REMISSION ON PHYSICAL
FUNCTION IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH ALX-0061:
POST-HOC ANALYSIS OF PHASE I/II DATA
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Authors: K. Van Beneden1, K. Verschueren1, W.
Willems1, H. Wouters1, J. D'Artois1, K. De Swert1, G. Arold2, S. De Bruyn1
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Year: 2014
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Session Info: Rheumatoid arthritis - other
biologic treatment
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ACR
Abstracts:
Abstract Number: 1498 2014 ACR/ARHP Annual Meeting
ALX-0061, an Anti-IL-6R Nanobody® for use in Rheumatoid Arthritis, Demonstrates a Different in Vitro Profile As Compared to Tocilizumab
Maarten Van
Roy1, Ariella Van De Sompel2, Kristi De Smet2, Jasper Jacobs2, Tinneke Denayer2
and Hans Ulrichts3, 1Department of Pharmacology, Ablynx N.V., Zwijnaarde,
Belgium, 2Ablynx N.V., Zwijnaarde, Belgium, 3Pharmacology, Ablynx N.V.,
Zwijnaarde, Belgium
And I’ve looked into this year’s EULAR and
ACR abstracts, as well as the published late breaking abstracts of this year’s
ACR Annual Meeting in Washington, which starts next weekend, but didn’t find
anything. So the data on the phase 2 studies is published on the Ablynx’s
homepage rather than published in scientific circles -: unusual, strange, and
suspicious.
If you look at the data supplied,
you see hardly any difference between placebo and vobarilizumab 225 mg Q2W in
ACR20 (74% vs. 74%) at week 24, but ACR50 is 39% vs. 59%, and ACR70 17% vs. 43.
All other dosages failed to show2 significance in the phase 2b study.
“Vobarilizumab has the potential to
be best of all classes” – a bold statement not based on head-to-head studies,
but data selected from other studies.
Vobarilizumab fared better in DAS28
response.
I hope that data will be published
on a scientific forum and not selected data on the homepage of a pharmaceutical
firm. How about the next EULAR Meeting? Or the Annals of Rheumatic Diseases?
Let’s do it the proper way, Ablynx!
What is Abbvie’s intention? Are
they looking for a substitute for adalimumab, once patent protection expires?
There are four adalimumab biosimilars, some ready for competition.
The big question remains – will the
phase 3 study really start? And when it starts, will vobarilizumab show a
significant reduction in radiographic progression. So, there are still years
before having a drug.
Links:
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