New Biologics at EULAR 2014: Stop and Wait

Article

(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.

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