Ablynx’s RA therapy matches Roche’s Actemra in Phase IIb trial

pharmafile | July 7, 2016 | News story | Medical Communications, Research and Development Ablynx, Actemra, Roche 

Ablynx (EBR: ABLX) has presented positive data on their rheumatoid arthritis treatment candidate, ALX-0061 (vobarilizumab), in patients with rheumatoid arthritis where the drug showed comparable efficacy to Roche blockbuster Actemra (tocilizumab).

AbbVie invested heavily in the drug with an upfront payment of $175 million in 2013. With the results of this Phase IIb now published, AbbVie must decide whether or not to exercise their right to take control of the drugs development, as per the terms of the deal.

The anti-IL-6R nanobody was tested as a monotherapy in patients with moderately to severely active rheumatoid arthritis who are intolerant to methotrexate or for whom methotrexate treatment is inappropriate. In the Phase IIb trial, ALX-0061 was directly compared to Actemra.

According to the efficacy parameters set up for the study, which were changes from baseline in the health assessment questionnaire disability score, ALX-0061 appeared to have a rapid positive impact on patient’s physical function. In patients on the highest dosage of the drug (225mg), 41% of those were in clinical remission at week 12, compared to 27% on Actemra. Furthermore, these comparable positive results were derived with less frequent administration than Actemra.

If AbbVie chooses to progress with the development of ALX-0061, then Ablynx could be eligible for milestone payments of up to $665 million, plus a cut of sales. With Actemra boasting annual sales well over $1 billion, there may be a new IL-6R drug set to join the RA market within the next few years.

Sean Murray

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