Biogen Plans Phase 3b Trial of Spinal Muscular Atrophy Drug
September 15 2021 - 8:15AM
Dow Jones News
By Matt Grossman
Biogen Inc. will launch a Phase 3b trial of nusinersen for
people with late-onset spinal muscular atrophy, testing a higher
dose level of the drug.
The study will focus on patients who have previously been
treated with Evrysdi, a Genentech Inc. drug. It aims to include
children, teenagers and adults, with enrollment set to begin this
year. In the two-and-a-half year study, patients will get two 50 mg
loading doses of nusinersen two weeks apart, following by a 28 mg
maintenance dose every four months, the company said.
Spinal muscular atrophy causes an insufficiency of survival
motor neuron protein, which helps maintain motor neurons that
enable sitting, standing and movement. People with the disease lose
the ability to do simple everyday tasks, Biogen said.
Nusinersen may help supplement treatment with Evrysdi because
Evrysdi shows a reduced drug concentration as patients' weight and
age increase. Motor neuron exposure to nusinersen remains similar
as patients age and grow, Biogen said.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
September 15, 2021 08:00 ET (12:00 GMT)
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