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.

Proof of Concept Study of ATN-103 (ozoralizumab) in Rheumatoid Arthritis

Roy Fleischmann and colleagues assessed in this multiple ascending dose / proof of concept study the safety and efficacy in subjects with active rheumatoid arthritis compared to placebo. ATN-103 (ozoralizumab), a novel TNF inhibitor, is a humanized, trivalent, bispecific Nanobody that contains 2 human TNF-binding domains linked to a human serum albumin-binding domain. Statistical significance compared to placebo for the primary endpoint was achieved by the 80 mg Q4 dose regimen only. Statistically significant improvements over placebo in secondary endpoints were achieved for 80 mg Q4 dose regimen in DAS28, ACR50, and more. The author’s didn’t see dose dependent increase in either AEs or SAEs or dose limiting toxicities.


[WED] 2630
A Multiple Ascending Dose/Proof of Concept Study of ATN-103 (ozoralizumab) in Rheumatoid Arthritis Subjects on a Background of Methotrexate.
Roy Fleischmann1, Savithree Nayiager2, Ingrid Louw3, Bernadette Rojkovich4, Caifeng Fu5, Chandrasekhar Udata6, Parvin Fardipour7, Bonnie Marshall7, Michelle Hinz7, Amarnath Sharma7, Kathy Shields7 and Gail Comer7.
1Metroplex Clinical Research Center, Dallas, TX, 2St. Augustine Hospital, Berea, KwaZulu-Natal, South Africa, 3Panorama Medical Centre, Panorama, Western Cape, South Africa, 4Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary, 5Pfizer, Cambridge, MA, 6Pfizer, La Jolla, CA, 7Pfizer, Collegeville, PA
Conclusion: The 80 mg Q4wk group was significantly better than PBO at week 16 in ACR20, ACR50, DAS28, HAQ-DI and other secondary endpoints. There was no dose dependent increase in either Aes or SAEs or dose limiting toxicities. Exposure to ATN-103 increased in a dose-proportional manner.