AbbVie Abandons Arthritis Pact with Ablynx
October 20, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In what feels like a bit of misdirection, Ghent, Belgium-based Ablynx (ABLYF) announced that it is wrapping up its Phase II trials and starting meetings with U.S. and European regulators about its anti-IL-6R Nanobody, vobarilizumab, in rheumatoid arthritis (RA). The company’s statement sidesteps that its partner, AbbVie (ABBV), is bailing on the deal, and that the company’s Phase IIb trial failed to meet its primary endpoint.
The company’s chief executive officer, Edwin Moses, does say, “We are obviously disappointed that AbbVie has decided at this time not to exercise its right to license vobarilizumab in RA. The strong Phase IIb results in RA demonstrated that vobarilizumab 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. We are absolutely committed to progressing this program and will therefore start the preparations for the Phase III study with the first patients expected to be enrolled by the end of 2017.”
Which is all well and good, although it’s the only mention of AbbVie in the entire press release. John Carroll, writing for Endpoints News, said, “The decision will come as no surprise to any careful observer of RA. The anti-IL-6R recently failed to pass muster in a Phase IIb trial, despite Ablynx’s best efforts to get analysts to look past the failure on the primary endpoint and on to more upbeat results in the study. And AbbVie already has an in-house rival that it’s been much more pumped about.”
In the Phase IIb trial, vobarilizumab was combined with methotrexate. But the combination did not meet its primary endpoint, which was to show at least 20 percent improvement on a disease rating score, ACR20, after 12 and 24 weeks of treatment. And only about 71 percent in the methotrexate arm showed a clinically meaningful improvement in physical function compared to 65 percent in the combination group. The combination did show a little better scores on ACR50 and ACR70, and for low disease activity.
But AbbVie, which paid $175 million upfront in the deal, also needed to evaluate vobarilizumab’s effectiveness against other drugs being developed for RA, such as baricitinib by Eli Lilly (LLY) and Incyte (INCY), sirukumab by GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ), and sarilumab by Regeneron (REGN) and Sanofi (SNY).
AbbVie also has its own in-house product for RA under development, ABT-494.
And this wouldn’t be the first time AbbVie threw up its hands on an RA partnership. In 2015, it ended a collaboration with Galapagos (GLPG) on its filgotinib. Carroll writes, “But Gilead immediately stepped in, paying $725 million to acquire partnership rights. Now Ablynx will face the task of finding someone willing to step into AbbVie’s shoes as well, trying to lure in partners with its positive ACR50 and ACR70 scores as well as upbeat results for low disease activity. But it will face some harsh comparison.”
Ablynx has argued that the placebo response is related to trial design and location, noting that it was strongest in Bulgaria, Georgia, and other countries involved in the trial that don’t have widespread biologicals available.
Writing for FierceBiotech, Nick Paul Taylor said, “Ablynx is claiming vobarilizumab has ‘dramatically better efficacy’ than Roche (RHHBY)’s Actemra and AbbVie’s Humira when given alongside methotrexate. But its claim is based on comparisons of data from different studies. When vobarilizumab was pitted against rival IL-6 drug Actemra in a Phase IIb monotherapy trial, it achieved comparable ACR20, ACR50 and ACR70 scores to the Roche drug. The one area vobarilizumab had an edge was in inducing low disease activity or remission.”
Which is likely why AbbVie took its toys and went home