By Michael Dabaie
Biogen Inc. said new research supports continued development of an investigational higher dose of Spinraza in spinal muscular atrophy.
Analysis of data from Phase 2 and Phase 3 studies in children with infantile-onset SMA suggests that a higher dose of Spinraza may lead to a clinically meaningful increase in the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders score beyond what was already observed with the 12 mg approved dose.
The data are being presented at the virtual Cure SMA Research & Clinical Care Meeting taking place June 9 to 11.
These findings reinforce the scientific rationale for evaluating a higher dose of Spinraza in the ongoing Devote Phase 2/3 study, Biogen said.
The company said it is presenting data reinforcing the long-term efficacy of Spinraza in a broad range of people with SMA
An analysis of data from a study shows 92% of patients who initiated Spinraza treatment as pre-symptomatic infants maintained the ability to swallow after a median of 3.8 years. In this analysis, study participants were consistently rated by their caregiver as, on average, never to rarely experiencing difficulty for the majority of measures related to general feeding, drinking liquids and eating solid foods, Biogen said.
In addition, post-hoc data from extension studies indicate children and teens with later-onset SMA showed improvement in walking distance over five years of Spinraza treatment and stabilization in fatigue, the company said.
Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals Inc.
Write to Michael Dabaie at firstname.lastname@example.org
(END) Dow Jones Newswires