Spinal Cord Injury
Other potential applications: traumatic brain injury, stroke
Spinal cord injury (SCI) refers to any injury 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 (NSCISC), 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 12,000 new injuries reported. Males account for the majority of spinal cord injury patients with 50-70% of those occurring in those aged 15-35.
Long-term complications from SCI can include neurologic impairments in any body system controlled by the affected nerves. There are no FDA-approved therapies indicated to treat, mitigate, or reverse SCI.
Traumatic brain injury (TBI) is caused by a blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain. TBI can cause a wide range of functional short- or long-term changes affecting thinking, sensation, 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.
According to World Health Organization, traumatic brain injury (TBI) will surpass many diseases as the major cause of death and disability by the year 2020. There are an estimated 10 million people worldwide affected annually by TBI. In the US, approximately 1.6 million people sustain a traumatic brain injury annually and TBI results in approximately 52,000 fatalities and 275,000 hospitalizations every year. 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.
AC105 in SCI and TBI
AC105 is a proprietary magnesium formulation licensed by Acorda in 2011. In preclinical studies, AC105 has demonstrated neuroprotective properties leading to improvement of locomotor function in SCI and cognitive function in TBI when therapy was initiated within four hours of injury. AC105 has completed Phase 1 trials in healthy volunteers and Acorda expects to initiate a Phase 2 clinical trial program in SCI, potentially expanding into other central nervous system indications, such as TBI and stroke. The U.S. Food and Drug Administration (FDA) granted Fast Track designation on February 12, 2009 for AC105 to improve functional recovery following treatment of acute SCI patients. Acorda expects to apply for FDA Orphan drug designation for the acute treatment of SCI and will explore Orphan drug designations in Europe and in other parts of the world given its worldwide development and commercialization rights.