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.
This language sounds more bearish than bullish, IMO. ATN-103 is a nanobody small-antibody drug (based on Ablynx’s llama-DNA platform) that targets TNF-alpha. PFE (Wyeth) licensed the IP from Ablynx in 2006 (#msg-14551776), and today’s PR is the first public update on this program, as far as I know.
“The notion that there’s a Chinese Wall between sell-side analysts and investment bankers may be the second-biggest piece of BS ever promulgated in any area of human knowledge!”