Biogen’s Phase II AFFINITY trial design for opicinumab in MS has mixed neurologist reception with strong inclusion rationale, though complex analysis steer reservations

15 Nov 2017

Biogen’s Phase II AFFINITY trial design for opicinumab in MS has mixed neurologist reception with strong inclusion rationale, though complex analysis steer reservations

Biogen’s (NASDAQ:BIIB) recently announced Phase II trial design for opicinumab in relapsing remitting multiple sclerosis (RRMS) has experts optimistic that patient inclusion criteria could allow a positive trial outcome. That said, the company’s decision to allow any disease-modifying therapy (DMT) in the trial had some experts noting overall data analysis would be challenging.

Some experts also noted lingering doubts on positive results considering previous mixed trial results and the drug’s uncertain mechanism of action.

Analysts have not commented on the trial design since it was announced in October. Experts noted that including patients with less disease duration, thus less axonal damage, makes sense given that patients with damaged axons are unlikely to benefit from the therapy. However, they noted the decision to allow opicinumab to be added to any DMT would add complexity to the trial analysis as multiple combinations would each require assessment. Still, the decision makes sense from a treatment/commercialization perspective.

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