AbbVie's $175 Million Gamble Pays Off as Ablynx RA Drug Meets Goal in Phase II Study

July 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff

GHENT, Belgium – Investors who may have been concerned about the future of Illinois-based AbbVie following the lapse of patent protection for Humira can breathe a sigh of relief after the company’s $175 million gamble on another rheumatoid arthritis treatment, Ablynx ’s vobarilizumab, is showing tremendous promise.

Belgium-based Ablynx announced that the company’s Phase IIb trial showed its nanobody drug was able to produce a clinical remission in up to 41 percent of patients. The mid-stage trial showed that vobarilizumab is highly effective and does not need to be taken as often as the rival RA drug, Actemra (tocilizumab).

The 12-week, 251-patient study of varying doses studied the safety and efficacy of the drug. More than 91 percent of the patients in the Phase IIb trial have accepted an offer to participate in an open-label extension study.

"We are very pleased with the positive outcome from this first Phase IIb study of vobarilizumab in RA. The goal of RA treatment is to improve the signs and symptoms of the disease, reduce disease activity, induce remission, and improve physical function. We believe the data clearly demonstrate the potential of vobarilizumab as an important new treatment option for patients suffering from RA. We look forward to reporting the data from the methotrexate combination therapy study in RA later this quarter,” Robert K. Zeldin, chief medical officer of Ablynx, said in a statement.

Shares of Ablynx jumped by 15 percent on Thursday, but have declined slightly this morning. Shares are currently trading at €12.70 as of 4.46 p.m. in Belgium.

Vobarilizumab targets the interleukin 6 pathway via its IL-6 receptor (IL-6R). IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation.

While Humira continues to be the top seller in the RA market and is responsible for a huge chunk of AbbVie’s revenue stream, Reuters noted that Ablynx’s drug could “underpin” AbbVie’s market-leading position in RA.

AbbVie and Ablynx struck an $840 million pact in 2013 to develop and commercialize the anti-IL-6R Nanobody, vobarilizumab.

While AbbVie is supporting the development of other RA treatments, the company continues to look for approval of expanded uses for Humira. Earlier this week, the company said it will present data from a Phase III trial using Humira to treat fingernail psoriasis. In its presentation, AbbVie said it will show Humira achieved at least a 75 percent improvement in moderate to severe fingernail psoriasis in patients compared with those receiving placebo. Earlier this month, Humira received FDA approval for the treatment of non-infectious intermediate, posterior and panuveitis, making it the first non-corticosteroid therapy available to adults dealing with the diagnosis. The European Commission also approved Humira in the European Union for the treatment of noninfectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in cases when corticosteroid treatment is inappropriate.