Stamulumab (MYO-029) is a recombinant human IgG1λ antibody that binds to myostatin and neutralizes its activity by preventing binding to its endogenous high-affinity receptor ActRIIB. Stamulumab leads to muscle fiber hypertrophy and not hyperplasia in SCID mice. Stamulumab has the potential for Becker muscular dystrophy (BMD), facioscapulohumeral dystrophy (FSHD), and limb-girdle muscular dystrophy (LGMD) research.
Stamulumab (MYO-029; ip; 1-10 mg/kg/week for 12 weeks) increases skeletal muscle mass in vivo in a concentration-dependent manner in SCID mice. Stamulumab leads to muscle fiber hypertrophy and not hyperplasia[1].
Stamulumab (i.v.; 1, 5, 20, 100 mg/kg/week for 4 weeks) has a central clearance (CL) of 0.25 mL/h/kg in C57/SCID mice[1].
Pharmacokinetic Parameters of Stamulumab (MYO-029)[1].
| C57/SCID mice IV (1-100 mg/kg/week for 4 weeks) | Sprague Dawley rats (2-50 mg/kg; single injection) | Cynomolgus monkeys (10-100 mg/kg/week for 5 or 39 weeks) | |
| CL (mL/h/kg) | 0.245 | 0.542 | 0.228 |
| Volume of central compartment (mL/kg) | 103 | 58.9 | 41.8 |
| Distributive clearance (mL/h/kg) | 1.79 | 0.815 |
References:
[1]. P Singh, et al. Translational Pharmacokinetic/Pharmacodynamic Analysis of MYO-029 Antibody for Muscular Dystrophy. Clin Transl Sci. 2016 Dec;9(6):302-310.
[2]. Kathryn R Wagner, et al. A phase I/IItrial of MYO-029 in adult subjects with muscular dystrophy. Ann Neurol. 2008 May;63(5):561-71.