Biogen announced that the first patient has been treated in the global clinical study, DEVOTE. The study is designed to evaluate the safety, tolerability and potential for even greater efficacy of SPINRAZA (nusinersen) when administered at a higher dose than currently approved for the treatment of spinal muscular atrophyspinal muscular atrophy (SMA).
Biogen announced updates to the SPINRAZA (nusinersen) clinical development program including the initiation of a new global clinical trial, DEVOTE.
New study, DEVOTE, to evaluate if SPINRAZA can offer even greater efficacy in treating SMA
Building on the demonstrated long-term safety profile and proven efficacy of SPINRAZA in a broad range of patients, the DEVOTE trial will examine the potential for even greater efficacy, as well as the safety and tolerability of SPINRAZA, when administered at a higher dose. The trial is a Phase 2/3 randomized, controlled dose-escalating study that will be conducted at 50 sites around the world with a projected enrollment of 126 individuals with SMA of all ages, including adults.