Tuesday, December 25, 2012

Ozoralizumab (ATN-103) at the ACR 2012 in Washington

“Ozoralizumab (ATN-103), a novel TNF-alpha inhibitor, is a trivalent, bispecific NanobodyR that potently neutralises TNF and binds to human serum albumin to increase its in vivo half-life.”

R. M. Fleischmann and colleagues presented: "A Novel Individualized Treatment Approach in Open-Label Extension Study of Ozoralizumab (ATN-103) in Subjects with Rheumatoid Arthritis On a Background of Methotrexate" (No. 1311). The study is a extension of the study, I’ve written about a year ago: http://rheumatologe.blogspot.de/2011/11/proof-of-concept-study-of-atn-103.html  Results: " ... EULAR good/moderate response rate was 97% ...". Conclusions: " ... This treatment approach could prove beneficial to patients and minimize treatment costs."

Interestingly the results had already been presented by Ablynx prior to the ACR 2012: http://www.marketwire.com/press-release/ablynx-announces-new-compelling-results-on-ozoralizumab-atn-103-rheumatoid-arthritis-brussels-ablx-1672854.htm  (“ABLYNX ANNOUNCES NEW COMPELLING RESULTS ON OZORALIZUMAB (ATN-103) IN RHEUMATOID ARTHRITIS.”). I think that’s premature. Please show some larger trials that have data on long term use and adverse events. And it is unclear, why this drug should be minimizing treatment costs. I’d call it wishful thinking at this stage of development. And I'd like to see more commitment by Ablynx - one study in 2011 and an extension of this study in 2012 isn't impressing.

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