- AbbVie's $175 million bet on Belgian drugmaker Ablynx's experimental IL-6 inhibitor received some validation Thursday, after a mid-stage study showed the drug matched Roche's Actemra in treating patients with rheumatoid arthritis.
- The higher dose of the drug, called vobarilizumab, edged out Actemra in improving tender or swollen joints as measured by ACR20, the primary endpoint for the trial. A lower dose given to roughly half of the participants performed slightly worse than Actemra however.
- Ablynx partnered with AbbVie in 2013 to develop vobarilizumab, receiving $175 million upfront with another $665 million in potential milestones. Thursday's results are important as AbbVie now will decide whether to in-license the drug, which would trigger new payments to Ablynx.
Ablynx has teamed up with half a dozen other major drugmakers to develop what it terms "nanobodies," which are derived from camel and llama antibodies. These single-domain antibodies are smaller than conventional antibodies and are structured differently, leading Ablynx to hope they might prove to be powerful building blocks for biologic medicines.
Vobarilizumab is one type of nanobody, designed to target the inteleukin 6 pathway to reduce inflammation.
Participants in the phase 2b study testing vobarilizumab as a monotherapy for treatment of rheumatoid arthritis (RA) were split into four groups, three of which were dosed with Ablynx's drug. The other group received Roche's Actemra.
While the higher 225-mg dose of vobarilizumab performed better than Actemra, the lower 150-mg dose came up just short of matching Actemra's ability to improve tender or swollen joints. The mixed performance might temper AbbVie's enthusiasm for licensing the drug.
But vaborilizumab also had a cleaner safety profile, with only 2.1% of patients discontinuing treatment compared to 6.3% of those receiving Actemra. Serious treatment-related adverse events cropped up in 0.5% of patients in the vaborilizumab group, compared to 3.1% of patients in the Actemra arm.
And vaborilizumab is administered subcutaneously once every two weeks rather than once a week for Actemra.
A second RA trial studying vaborilizumab in combination with methotrexate has wrapped up and is expected to read out data later in the third quarter. Ablynx CEO Edwin Moses told Reuters that he expects AbbVie to decide on whether to license the drug after results are published for that study.
AbbVie is looking for new drugs to replace an expected decline in revenue from its top-selling Humira, which faces looming generic competition. Humira is also indicated for rheumatoid arthritis.
Roche's Actemra pulled in nearly $1.5 billion in sales last year, and a similarly effective but safer and easier-to-administer competitor could eat into some of those sales. But AbbVie will need to hit on more drugs than just vaborilizumab to shore up the roughly $14 billion in Humira revenue.
Strong performance from its newer drugs Imbruvica and Venclexta would help, as would more promising results from its developmental drug Rova-T, which AbbVie acquired in its $5.8 billion buyout of Stemcentrx.