Pfizer's Anti-TNF-Alpha Nanobody Successfully Completes a Phase II Study and Demonstrates Clinical Proof-of-Concept in Patients With RA

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