AC105 is a proprietary magnesium formulation being developed by Acorda as a potential treatment for acute spinal cord injury (SCI) and considered for other CNS injuries such as traumatic brain injury (TBI) and stroke. In preclinical studies, AC105 has demonstrated neuroprotective properties leading to reduction of ultimate lesion size and improvement of functional recovery in SCI and TBI.
Acorda expects to initiate a Phase 2 clinical trial exploring the use of AC105 as a treatment for acute SCI in 2013. AC105 has received Fast Track designation from the FDA to improve functional recovery following treatment of acute SCI patients. Acorda was awarded a $2.67 million contract from the U.S. Department of Defense (DOD) in 2012 to support research of AC105 in SCI.
Spinal Cord Injury (SCI)
SCI refers to damage to the spinal cord that is caused by trauma, such as a motor vehicle accident, fall or sports injury. According to the National Spinal Cord Injury Statistical Center, there are between 183,000 and 230,000 people in the United States, and approximately 2 million people worldwide, living with a spinal cord injury. Each year, there are approximately 12,000 new injuries reported in the United States. Long-term complications from SCI can include neurologic impairments and there are currently no FDA-approved therapies approved to treat, mitigate, or reverse SCI.
Traumatic Brain Injury (TBI)
TBI is caused by a rapid change in velocity of the head such as occurs when struck by a moving object or when the head strikes a fixed object like a windshield. TBI can also be the result of a penetrating object such as a bullet injury. TBI causes a wide range of functional short- or long-term changes in the brain affecting thinking, sensation, sensorimotor function, language, or emotion. TBI can also cause epilepsy and increase the risk for conditions such as Alzheimer’s disease, Parkinson’s disease, and other brain disorders that become more prevalent with age.
In the US, approximately 1.6 million people sustain a TBI annually, resulting in approximately 52,000 fatalities and 275,000 hospitalizations. Approximately one-third of all hospitalized TBI survivors have long-term disability. TBI is a contributing factor to one third (30.5%) of all injury-related deaths in the United States. There are an estimated 10 million people worldwide affected annually by TBI.