New Biologics at EULAR 2014: Stop and Wait

Jul 03, 2014

(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 

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_8050150893668","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-IL-6R NanobodyPhase 1/2 

BI 655064

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"38","id":"media_crop_6405190124303","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-CD-40 MABNothing at  EULAR 2014 

Brodalumab 

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"36","id":"media_crop_369993880778","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-17 MABPhase 2 studies in PsoADoing fine, but the phase 3 study needs further recruiting.

BT061

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_6431061828153","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-CD-4 MABNothing at  EULAR 2014 

Clazakizumab

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_9259023639300","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-6 MABPhase 2b including radiographic dataShowed a phase 2b study including radiographic data. "I think that's promising."

Dekavil

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_351435597060","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

fibronectin-A-chain connected to IL-10one 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

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_4072245491408","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-CD-6 MABPhase 2 studyResults that "provide strong preliminary evidence for the safety and efficacy" [per abstract].

Ixekizumab

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_7960000814287","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-17 MABNothing new at  EULAR 2014; strange!Ixekizumab seems to be abandoned. "Usually the companies see that they publish a minor study."

Mavrilimumab

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_5863940787246","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-GM-CSFR-Alpha MABStill no phase 3 studyPresented in two studies, but no phase 3 study. "I guess that recruiting is a problem."

NNC0109-0012

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"36","id":"media_crop_9696500364629","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-IL-20 MABNothing at  EULAR 2014 

NNC0114-0005

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"38","id":"media_crop_6593198992295","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-IL-21 MABNothing at  EULAR 2014 

NNC0141-0100

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_8875737116060","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-NKG2a MABNothing at  EULAR 2014 

NNC0151-0000

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"38","id":"media_crop_5761240371029","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

anti-complement-factor-5a-receptor MABStopped because of side effects 

NNC0215-0384

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_8411732310019","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-complement-factor-5a-receptor MABPhase 1 

Ocaratuzumab

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_4389762998418","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

Fc- and Fab engineered anti-CD20 antibodyNothing at  EULAR 2014 

Olokizumab 

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_5743537422757","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-6 MABNothing at  EULAR 2014"Seems to be abandoned as nothing has been published" at EULAR2014. 

Ozoralizumab 

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"36","id":"media_crop_3487838832024","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

TNF-alpha inhibitor / trivalent, Nanobody (R)Nothing at  EULAR 2014 

Pateclizumab

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"38","id":"media_crop_5834213989322","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-Lymphotoxin-alpha MABNothing at  EULAR 2014 

SAN-300

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_8488048758145","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti Very late antigen-1 (VLA-1) MABNothing at  EULAR 2014Phase I results presented at ACR2013 "warrant further investigation."

Sarilumab

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_6438800646386","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-6 Receptor Alpha MABPhase 3 studyMet clinical, radiographic, and functional endpoints in a phase 3 study.

Secukinumab 

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_921402378363","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-IL-17a MABPhase 3 study, extracted data 

Tabalumab 

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_4962053641038","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"49"}}]]

anti-B Cell Activating Factor MABPhase 3 studyPhase 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

[[{"type":"media","view_mode":"media_crop","fid":"25639","attributes":{"alt":"","class":"media-image","height":"36","id":"media_crop_3692140420121","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2376","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

CD4 MABNothing at  EULAR 2014 

Veltuzumab

[[{"type":"media","view_mode":"media_crop","fid":"25638","attributes":{"alt":"","class":"media-image","height":"37","id":"media_crop_1963107313993","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2375","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","title":" ","typeof":"foaf:Image","width":"48"}}]]

CD20 MABNothing at  ACR13 

MAB = monoclonal antibody. Bracketed comments added by editor.

x