GHENT, Belgium, 17 May 2011 – Ablynx [Euronext Brussels: ABLX] today announced top-line results
from the recently completed POC Phase II clinical trial of ozoralizumab (ATN-103), an anti-TNF-alpha
Nanobody licensed to Pfizer, in patients with active rheumatoid arthritis (RA). The study evaluated five
different dosing groups plus placebo, and preliminary analysis of the data indicates that the study met
its pre-defined primary efficacy endpoint with the highest dose of ozoralizumab (80 mg every 4 weeks)
resulting in a statistically significant improvement of ACR20 responses compared with placebo at week
16. In addition, an improvement over placebo was also observed for secondary endpoints such as
improvements of clinical scores, DAS28, ACR50, ACR70 and EULAR response at this dose level at week
16. No dose limiting toxicities were observed, and the adverse events and serious adverse events that
did occur, did not show a clinically significant increase on increased dosing.
Pfizer have now confirmed that clinical proof-of-concept has been achieved and they are now engaged
in a full technical, clinical and commercial evaluation to determine whether and how to take ATN-103
forward.
Dr Edwin Moses, Chairman and CEO commented: “We are delighted to announce the first clinical proof-
of-concept for a Nanobody. This has extremely important implications for Ablynx, the whole Nanobody
technology platform and our R&D pipeline containing more than 25 programmes. Our progress has been
rapid and we are excited to have passed this critical milestone in our development into a potentially
leading biopharmaceutical company. We look forward to the completion of Pfizer’s internal decision
making process.”
About the clinical development programme
Pfizer successfully completed Phase I studies with ATN-103 in the summer of 2009, and then initiated
two randomized, double-blind Phase II trials in Japan, US and Rest of the World in September 2009,
which finished recruitment of a total of 312 patients in September 2010. In the US and Rest of the World
Phase II POC trial (not including Japan), 253 patients with active RA, on a stable background therapy of
methotrexate, were randomly assigned to four subcutaneous injections of ATN-103 in five dose groups
(10mg, 30mg, 80mg every 4 weeks; 10mg, 80mg every 8 weeks) or four subcutaneous injections of
placebo every 4 weeks. In February 2010, Pfizer started a long-term safety study for ATN-103, which is
an open-label extension study of the Phase II trials. The study is expected to be completed by the
beginning of 2012. |
