Earlier this month, the first human trials for myostatin inhibitors were published, revealing promising results. The study examined the effects of MYO-029, which is a recombinant human antibody that binds with a high affinity to myostatin and inhibits its activity.3 This myostatin-neutralizing antibody has previously been shown to increase muscle mass in mice by approximately 30 percent over three months.4 The study enrolled 136 subjects with various forms of muscular dystrophy. The subjects were randomized to three groups of MYO-029 dose escalation: group 1 received 1mg/kg; group 2 received 3mg/kg; and group 3 received 10mg/kg. Within each cohort, subjects were randomly assigned to receive the test drug or placebo. MYO-029 was administered intravenously every two weeks for six months (total of 13 doses). After the last dose, subjects were followed for three months. In this first-ever study of a myostatin inhibitor, the primary objective was safety. MYO-029 was well tolerated in the group of people with muscular dystrophies. No target-related side effects were identified to skeletal, smooth, or cardiac muscle. The most significant adverse events reported were skin reactions. Muscle mass was found to increase by approximately 2.4 percent in the 3mg/kg cohort; additionally there was a dose-dependent increase in fiber diameter in the 3 and 10mg/kg groups. The disappointing result of the study was that there were no increases in strength by the myostatin inhibitor. The myostatin drug seemed to have good tolerability at lower dosages, but at higher dosages many subjects experienced adverse skin reactions. The most exciting aspect of the study was that there were no adverse effects on the heart!
(MD)
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Originally Posted by Hazard
