On 7 July, Ablynx's (EBR:ABLX) stock jumped some 12% after releasing top-line data from its monotherapy Phase IIb ALX-0061 (vobarilizumab) study in rheumatoid arthritis (RA). Top-line results from a Phase IIb combination study are expected in 3Q16. AbbVie (NYSE:ABBV) has an option to license vobarilizumab in RA based on Phase IIb results.
While experts told BioPharm Insight that vobarilizumab is expected to be successful in its clinical development for RA, it is unlikely to differ much in efficacy from Roche's (VTX:ROG) Actemra (tocilizumab), another interleukin 6 (IL-6) inhibitor. Nonetheless, they added, the IL-6 target is promising, and the drug should be pursued in RA. But, experts noted, they would like to see Phase III studies comparing the drug head-to-head to an anti-TNF as well as in anti-TNF refractory patients, though this is not required by the FDA. This will be needed to further convince rheumatologists, but more so payers, that anti-IL-6s belong in the front line, they noted. They also pointed to the need for more data to understand safety differentiations between the IL-6 inhibitors and other MOAs.