Today, Genentech announced the discontinuation of emugrobart (an investigational anti-myostatin antibody, also known as GYM329) into Phase III development for spinal muscular atrophy (SMA).
The decision to stop clinical development of emugrobart in SMA follows a comprehensive assessment of the totality of the evidence from Part 1 of the MANATEE ( NCT05115110 ) study – a two-part, global Phase II/III study evaluating the safety and efficacy of emugrobart (GYM329) in combination with risdiplam. Unfortunately, emugrobart did not consistently deliver improvements in muscle growth and motor function compared to treatment with risdiplam alone in people living with SMA.
Cure SMA, along with Genentech, extends our sincerest thanks to the individuals and families who took part in the phase 1 trial of emugrobart (MANATEE).
For more information from Genentech and for a list of frequently asked questions, please see Genentech’s letter here.