Biogen Plans Phase 3b Trial of Spinal Muscular Atrophy Drug

 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 after 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.

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