Clinical Trials

Overview

GYM329

Developed by Roche, GYM329 (RO7204239) is an investigational anti-myostatin antibody that is designed to target skeletal muscles, potentially increasing their size and growth.  

 

The safety and efficacy of GYM329, in combination with risdiplam, are currently evaluated in a Phase 2/3 clinical study. The trial has two parts: Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years); Part 2 will assess the efficacy and safety of the GYM329 dose selected in Part 1 in a larger group of participants. 

Method of Action

GYM329 is an antibody that binds a protein called myostatin. Myostatin plays an important role in the regulation of skeletal muscle size by controlling growth. Inhibiting myostatin may help muscles grow in size and strength.

GYM329 in combination with risdiplam, which is designed to increase the amount of SMN protein throughout the body, has the potential to further improve motor function and outcomes for people living with SMA.

Trial of GYM329

Trial Name
Manatee
Age:
2 to 10 years old & 2 to 25 yrs.
Aim:
This trial will study the safety and efficacy of RO7204239 in combination with risdiplam in patients with spinal muscular atrophy (SMA). The trial has two parts; Part 1 is the dose-finding part in SMA patients that are either ambulant (aged 2-10 years) or non-ambulant (aged 5-10 years) within separate cohorts, and Part 2 is the pivotal part in SMA patients aged 2-25 years that are ambulant.
Status:
Part 1 - Active, not recruiting; Part 2: not yet recruiting
Locations:
Australia, Belgium, Canada, Croatia, Italy, Japan, Netherlands, Poland, Portugal, Spain, UK, USA
Identifier:
NCT05115110

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