GHENT, Belgium – Ablynx [Euronext Brussels: ABLX] 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 programs. 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 program
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.
For more information, please contact Ablynx:
Dr. Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
About Gilde Healthcare Partners
Netherlands-based Gilde Healthcare Partners (www.gildehealthcare.nl) is a transatlantic venture and growth capital firm focused on private healthcare technologies and services. It has over €400 million under management and is actively looking to lead new investments in therapeutics, diagnostics, medical devices and services. Gilde successfully builds healthcare businesses across Europe and US, investing up to €15 million in a single portfolio company. By investing in companies with clear achievable business models, Gilde has used its financial resources and network to create significant value for both its investors and the entrepreneurs it backs. For a list of Gilde’s portfolio companies please visit the website www.gildehealthcare.nl.