Drug Development

Will AbbVie bite? Decision time after Ablynx’s rheumatoid arthritis drug fails a key study

Ablynx has come to the crossroads with AbbVie on their blockbuster deal to develop a new IL-6 drug for rheumatoid arthritis. And the Belgian biotech company has some explaining to do.

This morning Ablynx released another messy set of Phase IIb data on vobarilizumab. Combined with methotrexate, the combination of vobarilizumab and methotrexate failed on the primary endpoint, unable to significantly distinguish itself on most outcomes tied to the key measure: An improvement of at least 20% on a disease rating score – ACR20 – after 12 and 24 weeks of treatment. The drug even fell short on measuring patients’ ability to function better, with 71% in the methotrexate arm reporting a clinically meaningful improvement in physical function compared to 65% taking a combination of vobarilizumab and methotrexate.

The drug/methotrexate combo did better on ACR50 and ACR70 scores as well as scores for low disease activity. But in an intensely competitive field, AbbVie is facing a Q4 deadline to decide whether it will buy the drug and square off against far more advanced rivals like Eli Lilly and Incyte (baricitinib), GSK and J&J (sirukumab) and Regeneron/Sanofi (sarilumab). AbbVie also has its own Phase III effort underway, which it has high hopes for.

Shares of Ablynx {Euronext Brussels: $ABLX} initially surged Tuesday, but slumped by mid-morning, trading down about 4%.

It can be hard to compare data on these drugs. Ablynx chose to simply select patients already on methotrexate to compare their combo. The competition, though, has been racking up late-stage successes among treatment-resistant patients or in head-to-head studies with AbbVie’s Humira, the world’s biggest drug franchise at $14 billion in 2015 revenue.

The latest data set comes just one month after Ablynx also demonstrated that their drug was at best a matchup against Roche’s Actemra (approved in 2010) on the key ACR scores, though it did better on disease activity scores.

Ablynx is painting all of this as a solid success pointing to “best-in-class potential,” hoping to persuade analysts to focus in on the high scores or easier treatment regimen for their drug and ignore what they’re calling a high placebo response. Payers, though, are likely to determine that the drug proves that generic methotrexate or an existing branded drug is either as good or almost as good as the experimental drug in combination with methotrexate. And it will have a hard time catching up with other drugs that are much farther along in the pipeline.

AbbVie has to decide now whether it will take a chance on the drug, and take it into Phase III as others are looking for an approval.

AbbVie paid $175 million upfront to partner with Ablynx on this drug, a big piece of an $840 million deal that gives AbbVie the option to take it through Phase III. AbbVie, though, can be distinctly unsentimental about marginal drugs, as it proved with its decision to bag its deal with Infinity after a successful, but commercially unconvincing, study of a lead cancer drug.

Michael Severino, Executive Vice President, Chief Scientific Officer, AbbVie

Michael Severino, Executive Vice President, Chief Scientific Officer, AbbVie

There’s also a preferred late-stage program at AbbVie to consider. Last fall, AbbVie axed a collaboration it has in place with Galapagos for their JAK1 inhibitor filgotinib (GLP0634), saying it preferred to take their in-house program for ABT-494 into Phase III for arthritis.

“We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders,” AbbVie CSO Michael Severino noted after the Phase II data came out in September. The Phase III started in January.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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