Follistatin 344

1. Follistatin 344 is an investigational protein therapeutic that builds muscle and increases strength by inhibiting molecules that bind to and signal through a cell surface receptor called Activin Receptor Type IIB (ActRIIB).

2. Follistatin 344 is a recombinant fusion protein that is produced by joining a portion of the human ActRIIB receptor to a portion of a human antibody.

3. Follistatin 344 is intended for research purpose only. ACE-031 should not be used for human consumption,diagnostic, therapeutic procedures, agricultural and veterinary purposes.ACE-031 is a soluble fusion protein that has been shown to increase muscle mass and strength in research studies.

4. Follistatin 344 is being studied as a treatment for metabolic diseases, renal neoplasms of childhood, cardiovascular anomalies, age-related muscle loss, and cancer treatment related muscle loss and neuromuscular diseases.

5. Follistatin 344 is a biologic therapeutic, based on activin receptor type IIB (ActRIIB). The molecule inhibits signaling via the ActRIIB receptor binding and increase muscle mass and strength. ACE-031 is a recombinant fusion protein that is artificially synthesized by fusion of standard antibody and a portion of ActRIIB receptor. The recombinant fusion protein eliminates myostatin and other biomolecules that limit muscle strength or growth.

6. Follistatin 344 belongs to class of proteins of TGF-beta super family that regulate muscle growth. ACE-031 acts on the molecular switches of these molecules and promote muscle growth. In experimental studies,

7. Follistatin 344 promotes muscle growth and inhibits ActRIIB receptor signaling. In pre-clinical studies, administration of ACE-031 for two weeks increased skeletal muscle density, decreased leptin levels, and increased adiponectin.