Pfizer Inc.'s Anti-TNF-Alpha Nanobody (ATN-103) Successfully Completes a Phase II Study and Demonstrates Clinical Proof-of-Concept (POC) in Patients With RA

GHENT, BELGIUM--(Marketwire - May 17, 2011) -

REGULATED INFORMATION

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.

Complete version of the press release: http://hugin.info/137912/R/1516627/452958.pdf

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Source: Ablynx via Thomson Reuters ONE

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