Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the first patient has been enrolled in a trial of
, its proprietary magnesium formulation for the treatment of spinal cord injury (SCI). This Phase 2 trial will evaluate the safety and tolerability of the drug in people with traumatic SCI, and also incorporates several exploratory efficacy measures.
“In preclinical studies, AC105 improved motor function in SCI when therapy was initiated within a few hours after injury,” said Andrew R. Blight, Ph.D., Acorda Therapeutics’ Chief Scientific Officer. “Spinal cord injuries often result in severe, lifelong disability, so we’re excited to explore the potential to improve outcomes for people who suffer these very serious injuries.”
Magnesium’s neuroprotective properties are well established in the laboratory; however, the tolerable dosage range in the clinic is relatively narrow, which has made it a challenge to develop a practical therapy. Preclinical research shows that AC105’s formulation helps deliver magnesium to the injury site within the CNS, thereby providing a protective effect, but without requiring higher levels in the blood, which might result in significant side effects.
The primary objective of this double-blind, randomized and placebo controlled study is to evaluate the safety and tolerability of AC105 in people who have suffered an SCI. The study also includes several exploratory efficacy measures, including standard scales used to assess motor function. Participants in the trial will receive six intravenous doses of AC105 or placebo over 30 hours; the first dose to be administered within 12 hours of the injury.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation for AC105 to improve functional recovery following acute SCI. The Company received a $2.67 million research contract from the U.S. Army Medical Research and Material Command to support the study. Acorda may potentially expand its AC105 program into other neurological injury indications.