Ablynx releases strong top-line data on vobarilizumab in RA

Belgian drug developer Ablynx (Euronext Brussels: ABLX) today announced compelling top-line results from a second Phase IIb rheumatoid arthritis (RA) study with its anti-IL-6R Nanobody, vobarilizumab, which showed that treatment with vobarilizumab strongly decreased signs and symptoms of rheumatoid arthritis (RA) in patients with moderate to severe disease already being treated with methotrexate (MTX).

Ablynx’ shares rose as much as 7% in early trading following release of the trial data on what has been billed as a blockbuster potential drug, but eased back to 13.50 euros, a 3.97% rise, by late morning.

The double-blind study enrolled 345 subjects in Europe, Latin America and the United States, who were randomly assigned to one of the four dose groups of subcutaneously (sc) administered vobarilizumab plus methotrexate [75mg every four weeks (Q4W), 150mg Q4W, 150mg Q2W, 225mg Q2W] or placebo plus methotrexate. Subjects were evaluated for efficacy up to and including week 24 and for safety up to and including week 34. Following completion of the 24-week treatment period, eligible subjects were invited to enroll in an open-label extension study of vobarilizumab, with 94% accepting. Subjects who were not eligible to roll over or who did not elect to do so were followed for safety for an additional 12 weeks after the last dosing. Evaluation is ongoing for a minority of these subjects.