Ablynx’ SLE antibody vobarilizumab miss endpoint

"We are disappointed that vobarilizumab didn’t show a dose response in the analysis of the study’s primary endpoint,“ said Robert Zeldin, Chief Medical Officer at Ablynx stating that vobarilizumab was well tolerated in all  tested four dose groups plus a placebo arm. Analyses of dose response were based on the mBICLA score (modified BILAG-based combined lupus assessment) at week 24.

Treatment-related serious adverse events through week 58 were reported in 2% of all vobarilizumab-treated patients compared to 6.5% in the placebo group. The percentage of patients experiencing a serious infection was also lower in the vobarilizumab arms compared to the placebo arm (2.8% vs. 6.5%). Treatment-emergent adverse events that led to study drug discontinuation were reported in 12.4% of all vobarilizumab-treated patients compared to 6.5% in the placebo group. Two deaths were reported in the vobarilizumab group. 

Previously, also Pfizer’s IL6-blocker PF-04236921 missed efficacy endpoints in SLE patients. Though Roche’s approved IL-6R-blocking arthritis medicine tocilizumab showed promising preliminary activity in a Phase I trail back in 2010, development of the humanised antibody wasn’t pushed forward  in this indication.