Roche and Genentech start MANOEUVRE – an new global phase 2 study of GYM329

MANOEUVRE: a new global Phase 2 study to begin by the end of the year
MANOEUVRE is a new global Phase 2 clinical study that aims to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics and efficacy of GYM329 (RO7204239), an investigational anti-myostatin antibody targeting muscle growth, in individuals living with FSHD.
As there are currently no approved treatments for FSHD, there remains a high unmet need for those living with the condition. This study draws on the ongoing need to assess new treatment options for FSHD and novel ways to improve muscle function and the motor abilities needed for daily living.

What is GYM329?
GYM329 is an investigational anti-myostatin antibody that is designed to target skeletal muscles, potentially increasing their size and growth. Myostatin plays an important role in the regulation of skeletal muscle size by controlling its growth. Inhibiting myostatin may help muscles grow in size and strength.
GYM329 has been engineered as a “recycling” and “sweeping” antibody, which means that it may be more efficient at removing myostatin from the blood compared to a conventional antibody.

Study overview
MANOEUVRE will assess the pharmacodynamics, tolerability, pharmacokinetics, safety, and efficacy of GYM329 in ambulant (able to walk independently) individuals aged 18-65 years with FSHD1 or FSHD2. The study plans to enrol approximately 48 participants.
This will be a placebo-controlled study, where eligible participants will receive either GYM329 or a placebo, every 4 weeks via a subcutaneous injection. The study will be double-blinded, meaning that neither the participant nor the study team will know who is receiving GYM329 or the placebo. Individuals will be asked throughout to take part in different assessments, including an MRI, muscle function and strength tests, completing questionnaires, and other evaluations. At the beginning of the study and then every 6 months thereafter, the participants will be asked to wear a digital device for a 4-week period that will help measure everyday upper and lower limb movement and capture changes to activities during normal daily living.
The study will conclude after all participants have completed 52 weeks of treatment. Participants will then have the option to continue for an additional 52 weeks, where all individuals involved will receive GYM329. Results from the trial will indicate if we move forward to a Phase 3 study.
Approximately 10 sites have been selected to participate in the study in four countries: Denmark, Italy, the UK and the United States. Enrolment is anticipated to start later in 2022. Anyone who is interested in joining the study should discuss treatment options with their physician. Further information on the MANOEUVRE study can be accessed on ClinicalTrials.gov.

About Roche and Genentech
Roche is a global biotech company focused on advancing science to improve people’s lives. We were founded 125 years ago in Basel, Switzerland, and now have a network of more than 100,000 employees working in 100+ countries. In the United States, our pharmaceutical division is called Genentech.