|Therapy||Pre Clinical||Phase 1||Phase 2||Phase 3||Approved|
Cimaglermin alfa (GGF2)
GGF2 is a member of the neuregulin growth factor family, and has been shown to promote recovery after neurological injury, as well as to enhance heart function in animal models of heart failure. GGF2 showed positive effects on cardiac function in the two Phase 1 clinical studies conducted to date. The Phase 1b trial assessed three doses of cimaglermin alfa in people with heart failure, but discontinued enrollment and then received an FDA clinical hold based on the occurrence of a case of markedly elevated bilirubin and liver enzymes. The FDA clinical hold was lifted in April 2017 after Acorda presented additional data on this effect, but the Company has not restarted any clinical studies. Acorda is currently deferring further investment in this program, and is considering next steps, which could include potential partnering or out-licensing.
rHIgM22 is a remyelinating antibody that has been studied for the treatment of multiple sclerosis (MS). MS is a chronic, usually progressive disease in which a person’s own immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin (a process known as demyelination) and eventually the nerve fibers themselves.
Data from two Phase 1 safety and tolerability trials, respectively in patients with MS and acute relapse in MS, showed that a single dose of rHIgM22 was not associated with any safety signals. The studies, which were not powered to show efficacy and exploratory measures, showed no difference between the treatment groups.
Acorda is currently deferring further investment in this program, and is considering next steps, which could include potential partnering or out-licensing.
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