A research contract newly awarded to Westchester-based Acorda Therapeutics Inc. could spur development of a drug used to treat spinal cord injuries in combat veterans.
Officials at Acorda’s Ardsley Park headquarters in Greenburgh said the U.S. Army Medical Research and Material Command has awarded the company a $2.67 million research contract to support development of AC105, a proprietary magnesium drug formulation being studied as a treatment for acute spinal cord injury (SCI).
Acorda will conduct a Phase 2 clinical trial primarily to assess the safety and tolerability of AC105 in SCI patients. The company plans to open enrollment for the study in the first half of this year.
“Spinal cord injuries often result in severe, lifelong disability, and primarily occur in young people,” Dr. Anthony Caggiano, vice president of research and development at Acorda, said in the announcement. “This leads to long-term care and quality of life issues for the person with the injury, as well as for their family and the health care system as a whole.” Caggiano called it “a privilege for us to be working on a therapy that may help those who have been injured in the line of duty.”
In preclinical studies, the drug product showed neuroprotective properties and improvement of locomotor function in spinal cord injury when therapy was begun within several hours of injury. The U.S. Food and Drug Administration (FDA) granted fast-track approval for AC105 as a therapy to improve functional recovery of acute SCI patients.
Acorda expects to apply for FDA orphan drug designation for AC105, a designation that can ease market approval and encourages development of drugs that treat rare medical conditions and have a limited commercial market. The company also will explore orphan drug designations in Europe and in other parts of the world.
Citing the National Spinal Cord Injury Statistical Center, Acorda officials said approximately 270,000 persons in the U.S. live with a spinal cord injury. Those traumatic injuries primarily affect young males, with 50 percent to 70 percent occurring in persons aged 15 to 35.