Study Drug ACE-083

What is ACE-083 and how does it work?

ACE-083 is an investigational drug that is being studied to increase muscle mass and strength in the muscles where it is injected. ACE-083 binds to proteins including activins and myostatin that regulate muscle growth. The main purpose of the A083-03 study is to see if the investigational medicine, ACE-083, can safely increase muscle size and strength in people with CMT1 or CMTX. The study drug is given as a series of injections into the muscle in the front of each lower leg once every three (3) weeks. ACE-083 is an "investigational" product and it has not yet been approved by the US Food and Drug Administration (FDA) or other regulatory authorities for treating patients. The study drug can only be used for research purposes in clinical research studies.

Have there been other clinical research studies using ACE-083?

Yes. Healthy people and people with facioscapulohumeral muscular dystrophy (FSHD), a rare genetic disorder that results in progressive muscle loss and weakness, have taken ACE-083 during their participation in clinical trials. Also, in part 1 of the A083-03 study, patients with CMT1 and CMTX were given ACE-083. In these previous clinical research studies, the drug has shown a favorable safety profile.

For more information on ACE-083, visit the manufacturer’s website.

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ACE-083 is an investigational product that is currently being studied and has not been approved by any regulatory agency for any use.