Ablynx Says Phase II Study Of Vobarilizumab Fails To Meet Primary Endpoint

(RTTNews) - Ablynx (ABLX) said Monday that the Phase II dose-ranging study of vobarilizumab, the Company's anti-IL-6R Nanobody, did not meet the primary endpoint of dose response based on the modified BILAG-based combined lupus assessment or mBICLA at Week 24.

Robert Zeldin, Chief Medical Officer at Ablynx, said, "We are disappointed that vobarilizumab didn't show a dose response in the analysis of the study's primary endpoint, however, vobarilizumab was well tolerated in all tested dose groups, confirming its favourable safety profile. We will continue to analyse the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study."

The study enrolled 312 patients with moderate to severe, active seropositive systemic lupus erythematosus (SLE) across five treatment arms (four dose regimens of vobarilizumab and placebo). Demographics and baseline characteristics were similar across treatment arms, and reflective of a typical SLE population.

Safety findings through Week 58 were favourable for vobarilizumab. Treatment-related serious adverse events were reported in 2.0% 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% versus 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.