A prospective multicentre open-label pilot study of Remedy Pharmaceuticals’ Cirara drug in patients with acute traumatic cervical spinal cord injuries has been initiated.
Up to five Level I trauma centres will be involved in the trial, including University of Ohio Wexner Medical Center, USA, as the principal site. The study’s Principal Investigator is H Francis Farhadi, clinical assistant professor, Department of Neurological Surgery and Director, Spinal Surgery Fellowship Program at The Ohio State University, USA.
According to the World Health Organization, annually there are between 133,000 and 226,000 cases of spinal cord injury worldwide, with approximately 12,000 new cases each year in the USA. Presently, over 250,000 people in the USA are living with a spinal cord injury.
“There are currently no standard of care pharmaceutical strategies for the treatment of acute traumatic spinal cord injury,” notes Sven Jacobson, chief executive officer of Remedy Pharmaceuticals. “There remains a dire need for new therapies that will give hope to these patients and their families, who otherwise face years, even a lifetime of painful recovery, and often full paralysis.”
Spinal cord injury causes progressive haemorrhagic necrosis, leading to devastating loss of spinal cord tissue. Emerging evidence points to the Sur1–Trpm4 channel as the molecular precursor of progressive haemorrhagic necrosis. Data from preclinical and human clinical studies has suggested that Remedy Pharmaceuticals’ drug candidate, Cirara, closes this channel, inhibiting spinal cord oedema and micro haemorrhage formation.
The study will enrol and treat up to a maximum of 10 patients who will be matched in a 1:3 ratio with historical controls. Patients with cervical (C4–C8) level complete or incomplete injuries who are aged 18–70 years old will be eligible for inclusion in the study.
The data obtained from this pilot study should inform the design of further multicentre phase II/III clinical studies evaluating the efficacy of Cirara in improving functional outcomes following spinal cord injury.