By Colin Kellaher
Biogen Wednesday said it will launch a new study to evaluate whether a higher dose of Spinraza can provide greater efficacy in the treatment of the neuromuscular disease spinal muscular atrophy.
The Cambridge, Mass., biopharmaceutical company said it will conduct the phase 2/3 study at 50 sites around the world, with a projected enrollment of 126 patients of all ages.
Biogen said the trial will compare two loading doses of 50 milligrams 15 days apart followed by a maintenance dose of 28 milligrams every four months with the current FDA-approved program of four loading doses with 12-milligram maintenance doses every four months.
Spinal muscular atrophy is a rare genetic disease characterized by a loss of motor neurons in the spinal cord and lower brain stem, resulting in severe, progressive muscle atrophy and weakness.
Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals, which receives royalties on sales of the drug.
Write to Colin Kellaher at email@example.com