Are you familiar with ACE-031?
I. What is ACE-031?
ACE-031 is a recombinant fusion protein (ActRIIB-Fc) formed by the fusion of the extracellular domain of the activin receptor IIB (ActRIIB) and the IgG1-Fc fragment. It acts as a "decoy receptor" for myostatin and TGF- superfamily ligands, blocking their signal transduction, relieving muscle growth inhibition, and promoting muscle proliferation and repair.
II. Product Parameters
Full Name: Activin Receptor IIB-Fc Fusion Protein (ACE-031)
Alias: Myostatin inhibitory peptide 7
Molecular Formula: C₁₃₃H₂₂₇N₄₃O₃₃; Molecular Weight: 2956.5
Purity: >=99% (HPLC)
Specifications: 1mg/vial, 5mg/vial
Storage: Dry powder can be stored for 3 years at -20℃, 2 years at 4℃; after reconstitution, it can be stored for 1 month at -20℃, 6 months at -80℃
Half-life: Relatively long (approximately several days), suitable for weekly injection
III. Product Functions and Core Advantages
The core function of ACE-031 is as a "decoy receptor," circulating in the body and binding to proteins such as myostatin. Myostatin is a naturally occurring "brake" protein in the human body that limits excessive muscle growth. By neutralizing these inhibitory signals, ACE-031 can remove the limitations on muscle growth, thereby promoting muscle hypertrophy and strength enhancement.
Highly effective muscle growth: Clinical data show that a single dose can significantly increase overall lean body mass and thigh muscle volume in a short period.
Multiple benefits: In addition to muscle growth, studies have also shown that it may have a positive effect on improving bone strength and fat metabolism.
Long-lasting effect: A half-life of 10-15 days means that frequent dosing is not required.
IV. Clinical Value and Development History
The development of ACE-031 has primarily focused on the treatment of muscular atrophy diseases, particularly Duchenne muscular dystrophy (DMD), and has received Orphan Drug Designation and Fast Track designation from the US FDA.
In a Phase I clinical trial in healthy postmenopausal women, a single injection of ACE-031 at a dose of 3 mg/kg showed significant muscle growth after 29 days: an average increase of 3.3% in total lean body mass and an average increase of 5.1% in thigh muscle volume.
However, in a Phase II clinical trial in patients with DMD, development of the drug was terminated due to unexpected side effects such as nosebleeds and telangiectasia (small red blood vessels appearing on the skin surface). Despite the trial failure, it provided valuable experience and data for the subsequent development of myostatin inhibitors.
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