Pfizer Ph II study confirms efficacy of Ablynx' ozoralizumab in RA

Belgian drug developer Ablynx (Euronext Brussels: ABLX) revealed  top-line results from the recently completed proof-of-concept Phase II clinical trial of ozoralizumab (ATN-103), an anti-TNF-alpha nanobody licensed to US pharma behemoth Pfizer (NYSE: PFE), 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 (80mg every four weeks) resulting in a statistically significant improvement of ACR20 responses compared with placebo at week 16.

While Ablynx’ license agreement with Pfizer for anti-TNF arthritis treatments is potentially worth as much as $212.5 million excluding royalties on sales, the findings of the study mark the first time that an Ablynx-developed drug has shown clinical efficacy in patients, commented Bloomberg.