Ablynx initiates meetings with FDA, EMA for vobarilizumab

Ablynx recently announced it will begin the end-of-phase 2 process with the FDA and the European Medicines Agency for vobarilizumab, an anti-interleukin-6 nanobody for the treatment of rheumatoid arthritis, according to a company press release.

Edwin Moses

“We are obviously disappointed that AbbVie has decided at this time not to exercise its right to license vobarilizumab in [rheumatoid arthritis] RA,” Edwin Moses, PhD, chief executive officer of Ablynx, said in the release. “The strong phase 2b results in RA demonstrated that vobarilizumab in is not just another antibody, but a member of a new therapeutic class with unique differentiating features resulting in a superior efficacy and safety profile as compared to other biologicals.”

According to the release, nanobodies are proteins based on single-domain antibody fragments. This therapeutic class combines features seen in antibody drugs with features seen in small-molecule medications.

In a 24-week phase 2b trial, vobarilizumab in combination with methotrexate had an ACR20 of 79%, an ACR50 of 59% and an ACR70 of 43% for patients with moderate to severe RA. Based on the DAS28, up to 49% of treated patients achieved remission at week 24. While there was no significant difference in 12-week ACR20 response between combination therapy and methotrexate monotherapy, the researchers attributed the difference to an unusually high placebo response. Despite this, the drug will move on to phase 3.

Reference: