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(EULAR2014) Which candidate biologics for rheumatology are destined to pass "Go" and collect? A member of the audience at the recent conference presents his observations and comments.
Tallying the list of presentations about new biologics at the 2014 annual meeting of EULAR (the European Union League Against Rheumatism) against what he's heard before, German rheumatologist Lothar Kirsch prepared the following table of drug candidates that appear still promising, or otherwise.
Given that many drug candidates for rheumatic diseases eventually approved in the United States begin their useful lives in Europe, we present the information below for your interest.
We have adapted Dr. Kirsch's table, with his permission, adding some comments from his blog Rheumatologe. We include his useful traffic-light system for highlighting the likely survivors.
"Usually the companies see that they publish a minor study" (at the next large rheumatology conference), he observes in his comments about one of these drugs. Thus sometimes he sees absence of any new studies at EULAR2014 as evidence that development of the drug is slowed or stopped. Evidently, however, in some cases he still sees reason for optimism.
Dr. Kirsch is a rheumatologist at St. Elizabeth Hospital in Meerbusch, Germany.
[See the table below. If you have reason to disagree with one of these assessments, please add a comment in the box below the table.]
ALX-0061
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anti-IL-6R Nanobody | Phase 1/2 |
BI 655064
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anti-CD-40 MAB | Nothing at EULAR 2014 |
Brodalumab
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anti-IL-17 MAB | Phase 2 studies in PsoA | Doing fine, but the phase 3 study needs further recruiting. |
BT061
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anti-CD-4 MAB | Nothing at EULAR 2014 |
Clazakizumab
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anti-IL-6 MAB | Phase 2b including radiographic data | Showed a phase 2b study including radiographic data. "I think that's promising." |
Dekavil
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fibronectin-A-chain connected to IL-10 | one study, much same as before | 7 patients presented at EULAR 2013, 14 patients at ACR 2013, now 20 patients, recruited in 4 different centers. "I don't see the future of this approach as favorable as the authors [do]." |
Itolizumab
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anti-CD-6 MAB | Phase 2 study | Results that "provide strong preliminary evidence for the safety and efficacy" [per abstract]. |
Ixekizumab
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anti-IL-17 MAB | Nothing new at EULAR 2014; strange! | Ixekizumab seems to be abandoned. "Usually the companies see that they publish a minor study." |
Mavrilimumab
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anti-GM-CSFR-Alpha MAB | Still no phase 3 study | Presented in two studies, but no phase 3 study. "I guess that recruiting is a problem." |
NNC0109-0012
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anti-IL-20 MAB | Nothing at EULAR 2014 |
NNC0114-0005
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anti-IL-21 MAB | Nothing at EULAR 2014 |
NNC0141-0100
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anti-NKG2a MAB | Nothing at EULAR 2014 |
NNC0151-0000
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anti-complement-factor-5a-receptor MAB | Stopped because of side effects |
NNC0215-0384
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anti-complement-factor-5a-receptor MAB | Phase 1 |
Ocaratuzumab
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Fc- and Fab engineered anti-CD20 antibody | Nothing at EULAR 2014 |
Olokizumab
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anti-IL-6 MAB | Nothing at EULAR 2014 | "Seems to be abandoned as nothing has been published" at EULAR2014. |
Ozoralizumab
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TNF-alpha inhibitor / trivalent, Nanobody (R) | Nothing at EULAR 2014 |
Pateclizumab
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anti-Lymphotoxin-alpha MAB | Nothing at EULAR 2014 |
SAN-300
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anti Very late antigen-1 (VLA-1) MAB | Nothing at EULAR 2014 | Phase I results presented at ACR2013 "warrant further investigation." |
Sarilumab
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anti-IL-6 Receptor Alpha MAB | Phase 3 study | Met clinical, radiographic, and functional endpoints in a phase 3 study. |
Secukinumab
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anti-IL-17a MAB | Phase 3 study, extracted data |
Tabalumab
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anti-B Cell Activating Factor MAB | Phase 3 study | Phase 3 study (N=456) in two abstracts "demonstrated no clinical efficacy despite evidence of biologic activity, suggesting that targeting BAFF may not be a viable therapeutic approach to treating pts with RA." [per abstract] |
Tregalizumab
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CD4 MAB | Nothing at EULAR 2014 |
Veltuzumab
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CD20 MAB | Nothing at ACR13 |
MAB = monoclonal antibody. Bracketed comments added by editor.