Acorda Therapeutics said today it won a $2.67 million contract from the U.S. Army Medical Research and Material Command (USAMRMC) to support development of AC105 as a treatment for acute spinal cord injury (SCI).
The contract will help fund a Phase II clinical trial designed primarily to assess the safety and tolerability of AC105 in patients with acute SCI. The company plans to open enrollment for this study in the first half of this year.
AC105, a modified form of magnesium, has shown neuroprotective properties and improvement of locomotor function in SCI in preclinical studies, once therapy was initiated within several hours of injury. FDA has granted fast-track designation for AC105 to improve functional recovery of acute SCI patients.
Acorda said in a statement that it expects to apply for FDA orphan drug designation for acute treatment of SCI, and will explore orphan drug designations in Europe and elsewhere in the world.
Acorda licenses worldwide development and commercialization rights to AC105 from Medtronic, which carried out the drug candidate’s Phase I study. Under a 2011 agreement, Acorda paid Medtronic $3 million up-front, and agreed to pay up to $32 million tied to regulatory and development milestones. If Acorda successfully commercializes AC105, the company will also pay Medtronic a single-digit sales royalty.
Acorda's rights are exclusive for indications of interest to the company—including SCI, traumatic brain injury, stroke, and all other traumatic and ischemic central nervous system indications. Medtronic and Acorda share nonexclusive development rights in other specific areas, including certain areas of pain and musculoskeletal indications.
At the time, Acorda said it acquired rights to AC105 as a complement to its lead neuregulin drug candidate, Glial Growth factor 2 (GGF2), as well as to the company’s preclinical programs in remyelination and spinal cord injury. Acorda envisions AC105 for several nervous system and cardiac indications including heart failure, peripheral nerve damage, stroke, multiple sclerosis, and SCI.
Last month, the company completed its first Phase I clinical trial of GGF2, which explored the drug’s safety and tolerability in heart failure patients.