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:
[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
Authors: K. Van Beneden1, K. Verschueren1, W. Willems1, H. Wouters1, J. D'Artois1, K. De Swert1, G. Arold2, S. De Bruyn1
Session Info: Rheumatoid arthritis - other biologic treatment
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.
Ablynx - http://www.ablynx.com/uploads/data/files/161019%20vobarilizumab%20phase%20iib%20additional%20results_final.pdf