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Biogen multiple sclerosis drug flunks clinical trial

Opicinumab had been proposed as a possible reparative therapy in MS


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

The news is particularly 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. Biogen's chief medical officer Alfred Sandrock said that due to the complex nature of the data, "we continue to analyse the results to inform the design of our next study."

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.

Biogen's shares fell on the announcement as investors digested the news, which adds to pressure on the company's core MS franchise resulting from declining sales of its injectable beta interferon products Avonex and Plegridy and lower-than-hoped-for volume growth for oral therapy Tecfidera (dimethyl glutamate). 

Last year, the company reduced its workforce and cut research projects in a bid to slash $250m off its annual expenditures.

Article by
Phil Taylor

8th June 2016

From: Research



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