Biogen is cutting its experimental multiple sclerosis (MS) drug opicinumab as well as an spinal muscular atrophy (SMA) candidate amid a third-quarter clear-out.
First, to its MS drug. In its third-quarter financials posted Wednesday morning, the biopharma said: “In October 2020 Biogen announced that the phase 2 AFFINITY study of opicinumab in MS did not meet its primary or secondary endpoints and that Biogen has discontinued development of opicinumab.”
The anti-LINGO monoclonal antibody has experience with failure: All the way back in 2016, it posted a similar phase 2 flop after not hitting its primary and secondary endpoints for MS in the so-called SYNERGY trial.
Back then, opicinumab was seeing whether it could have an effect on a “multicomponent” primary endpoint designed to assess ambulation, upper extremity function and physical disability in patients with relapsing forms of MS. Opicinumab, however, failed to outperform placebo in this regard.
A secondary efficacy endpoint, intended to evaluate the slowing of disability progression, also came up negative. But Biogen dug through the data, and, instead of culling it then and there, decided to carry on, saying: “While we missed the primary endpoint, the SYNERGY study results suggest evidence of a clinical effect of opicinumab.”
Biogen believed the data showed an increased clinical effect of opicinumab versus placebo (when used at the same time as interferon beta-1a intramuscular injection).
That led to the AFFINITY study, started in 2017, which looked at opicinumab as an add-on therapy in patients who are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone.
The primary endpoint of the study, overall response score, looked to assess the improvement and worsening of disability over time. Clearly, it failed to achieve this, though in its third-quarter update it did not reveal further details.
It also quietly announced it was throwing out BIIB089, an SMA gene therapy hopeful that had been on an IND hold due to “dorsal root ganglion toxicity.” Again, it did not any extra color to this cull in its financials.
The biopharma is now pinning its hopes on another failed drug, aducanumab, which it hopes can get past an FDA advisory committee early next month and a potential approval next year, though this controversial Alzheimer’s disease asset has been given low odds by analysts of managing that feat.