Biogen Shoots Up Following Positive Eye Drug RENEW Trial Data

Biogen Shoots Up Following Positive Eye Drug RENEW Trial Data
April 15, 2015
By Alex Keown, Breaking News Staff

CAMBRIDGE, Mass. – Biogen, Inc.’s stock opened strong this morning following the company’s announcement of positive results of from a mid-stage study testing anti-LINGO-1 for the treatment of acute optic neuritis (AON).

The clinical trial, dubbed RENEW, is attempting to demonstrate the repair of nerve fibers through the process of remyelination (the formation of new myelin on axons) after an inflammatory injury, according to a report in Results from the study showed improved latency recovery among anti-LINGO-1 participants, compared with placebo. Study participants, those treated with at least five of six doses of anti-LINGO-1, showed a 34 percent improvement of 7.55 milliseconds in optic nerve conduction latency at week 24, according to a Biogen press release.

Acute optic neuritis is an inflammation of the optic nerve the bundle of nerve fibers that transmits visual information from your eye to your brain, according to the Mayo Clinic. Those who are afflicted with AON often experience acute pain and vision loss. AON is associated with multiple sclerosis. In some people, signs and symptoms of optic neuritis may be the first indication of multiple sclerosis, the Mayo Clinic said on its website. Due to their close link, some MS drugs are often provided to patients with AON to prevent or delay the development of MS. Drugs often prescribed include interferon-beta 1a medications such as Biogen's Avonex or Pfizer Inc. ’s Rebif. Those who are considered high-risk for MS are sometimes prescribed interferon-beta 1b drugs such as Bayer’s Betaseron and Novartis AG ’ Extavia.

There are about 2.5 million people diagnosed with multiple sclerosis across the globe, with about 400,000 in the United States.

"We believe the anti-LINGO-1 data point toward a potential new approach to treating demyelinating diseases, and we look forward to the ongoing Phase 2 SYNERGY study results to further clarify the potential of this investigational therapy in MS,” Alfred Sandrock, Biogen’s chief medical officer said in a statement.

While RENEW showed promise with remyelination, the study showed no effect on the secondary endpoints of change in thickness of the retinal layers (optic nerve neurons and axons) or visual function. As a result, anti-LINGO-1 may not have had an opportunity to provide evidence of neuroprotection in this study, Biogen said.

“We believe that the opportunity to impact neuroprotection was limited by the rapidity with which retinal ganglion cells and their nerve fibers were damaged by the disease. This insight offers valuable information on the speed of axonal loss following an AON attack, and combined with the positive primary endpoint results, will help inform future studies,” Sandrock said.

Biogen is conducting separate clinical trials, dubbed SYNERGY, to test anti-LINGO-1 for use with relapsing forms of multiple sclerosis. Results of the Phase II trials are expected in 2016.

While the results of the trial may be positive, several physicians who specialize in multiple sclerosis told Forbes that anti-LINGO-1 will need further study.

Still, the news has helped Biogen’s stock, which had a morning high of $430.96 per share.

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