AbbVie rejects Ablynx RA drug on cusp of PhIII

Ablynx's home city of Ghent, Belgium(By Alvesgaspar - Own work, CC BY-SA 3.0,

AbbVie ($ABBV) has turned down a chance to license Ablynx’s (EBR:ABLX) Phase III-ready anti-IL-6R antibody vobarilizumab. The Big Pharma had an option to pick up the rheumatoid arthritis drug for $75 million (€68 million), but the Phase II data package put together by Ablynx has failed to convince it to pay up.

Ghent, Belgium-based Ablynx now plans to move vobarilizumab toward a Phase III trial while looking for a new partner. The current schedule has Ablynx talking to regulators about the next steps for the program in the first half of 2017, with a view to getting a Phase III trial underway before the end of the year. In parallel, Ablynx will seek out a partner that can fill the financial and late-phase R&D experience gaps left by AbbVie.

The situation is similar to the one Galapagos ($GLPG) found itself in a little more than one year ago. Like Ablynx, Galapagos had been waiting for AbbVie to decide whether to pick up its rheumatoid arthritis drug and advance it into Phase III. And, like Ablynx, Galapagos was jilted by AbbVie and left looking for another partner.

Galapagos emerged trailing AbbVie in the race to bring a JAK1 inhibitor to market, but with a lucrative pact with Gilead ($GILD) to soften the blow. Ablynx will be hoping to pull off a similar trick, although it is questionable whether its data are as compelling as those Galapagos had going into its partnering discussions.

Ablynx is claiming vobarilizumab has “dramatically better efficacy” than Roche’s ($RHHBY) 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.

That trial formed one part of Ablynx’s case for vobarilizumab.

The second part was a Phase IIb trial that compared four vobarilizumab-based regimens with a placebo. Between 72% and 81% of participants in the experimental treatment arms experienced a 20% improvement in their symptoms. Unfortunately for Ablynx, 62% of subjects in the placebo cohort also improved to that extent. The upshot was the trial missed its primary endpoint, although Ablynx pointed to the efficacy, safety profile and dosing schedule as evidence the drug had a future.

Ablynx has since presented data showing the placebo response was strongest in Bulgaria, Georgia and other countries that lack widespread access to biologicals. This, Ablynx argues, shows the strong placebo response is “clearly related to trial design and location.”

With AbbVie already powering its JAK1 inhibitor ABT-494 through a handful of Phase III trials, the overall argument has failed to convince it vobarilizumab is an essential addition to its pipeline. The question now for Ablynx is whether another company will bite and, if so, how much cash they are willing to put up.

Shares in Ablynx opened down 15% following the news