Muscle GrowthPhase II

ACE-031

ActRIIB-Fc

A discontinued ActRIIB-Fc fusion protein that acted as a myostatin trap. Development halted in 2011 due to bleeding-related safety concerns.

What is ACE-031?

ACE-031 was a soluble form of ActRIIB (Activin Receptor Type IIB) developed by Acceleron Pharma as a myostatin inhibitor for muscular dystrophy. It acts as a "trap" for myostatin and related ligands, preventing them from inhibiting muscle growth.


Development History

  • Developed for Duchenne muscular dystrophy
  • Phase 2 clinical trials conducted
  • Discontinued due to safety signals
  • Primarily nosebleeds and gum bleeding
  • Development halted in 2011

Mechanism

Ligand Trap

ACE-031 works by:

  1. Circulating as soluble receptor
  2. Binding myostatin and GDFs
  3. Preventing muscle inhibition
  4. Allowing enhanced muscle growth

Clinical Results (Before Discontinuation)

Phase 2 showed:

  • Increased lean mass
  • Improved muscle volume
  • But safety concerns emerged
  • Bleeding-related adverse events

Current Status

Discontinued

  • Development stopped
  • Safety concerns unresolved
  • Related compounds in development
  • Acceleron pursued other programs

Summary

Key Points:

  • Classification: ActRIIB-Fc fusion
  • Mechanism: Myostatin trap
  • Status: DISCONTINUED
  • Reason: Safety concerns (bleeding)

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