Article

July 3, 2014

New Biologics at EULAR 2014: Stop and Wait

(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.