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Biogen multiple sclerosis drug fails clinical trial (08/06/16)

Biogen has been bit by the failure of its multiple sclerosis candidate opicinumab to show efficacy in a phase II trial.

The news is disappointing as the antibody had been proposed as a possible reparative therapy in MS, reversing the nerve damage that occurs with the disorder rather than simply halting its decline.

Opicinumab (also known as BIIB033) targets a cellular factor called LINGO-1, a drug target that has been pursued by Biogen and its academic collaborators for more than a decade.

LINGO-1 is a membrane protein that suppresses myelination - the formation of the sheath around nerves that is stripped away in MS. By halting the activity of LINGO-1, Biogen hoped to restore the ability of nerves to create new myelin sheaths in place of those that have been lost.

In the phase II SYNERGY trial, however, opicinumab failed to improve physical function and cognitive function or slow the progression of disability in patients with the relapsing form of MS, although Biogen said the trial had revealed "evidence of a clinical effect with a complex, unexpected dose-response."

The company has not abandoned the programme just yet, but hopes of a phase III programme have all-but receded.

Opicinumab is also in testing as a treatment for optic neuritis, and once again the clinical picture is mixed in this indication. The results of the RENEW study reported last year showed that while there was evidence of an improvement in the function of the optic nerve, there was no benefit on patients' eyesight and other biomarkers.

Source: PMLiVE, 08 June 2016, Phil Taylor