MediciNova Starts Phase 2/3 Trial of Med for Degenerative Cervical Myelopathy

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it plans to initiate a Phase 2/3 trial of MN-166 (ibudilast) in degenerative cervical myelopathy (DCM) in collaboration with the University of Cambridge.

This clinical trial is being conducted under an agreement between MediciNova, the University of Cambridge, and Cambridge University Hospitals NHS Foundation Trust. Funding for this clinical trial is being provided by the National Institute for Health Research (NIHR) in the United Kingdom (UK). The Principal Investigator is Dr. Mark Kotter, NIHR Clinician Scientist, Honorary Consultant in Neurosurgery at the University of Cambridge. This trial will evaluate MN-166 (ibudilast) as an adjuvant treatment for DCM following spinal surgery and determine whether MN-166 (ibudilast) is more effective than placebo in improving outcomes after spinal surgery. Nonclinical studies have shown that inhibiting PDE-4, a well-established mechanism of action of MN-166 (ibudilast), promotes nerve growth in a traumatic spinal cord injury model. This re-growth in the spinal cord may lead to partial or complete recovery of function in DCM patients. MediciNova will provide the study drug supply, regulatory support, and safety monitoring support.

Mark Kotter, MD, Principal Investigator of the study, commented, “We are excited to collaborate with MediciNova to evaluate MN-166 for the treatment of degenerative cervical myelopathy. We believe MN-166’s ability to induce nerve re-growth has potential clinical utility in DCM.”

According to Myelopathy.org, degenerative cervical myelopathy (DCM) is defined as compression of the spinal cord in the neck which can lead to paralysis. DCM is a common, progressive neurological disease caused by aging, arthritis, and degenerative spinal conditions such as spinal stenosis and central disc herniation. According to the American Association of Neurological Surgeons, more than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots. Compression of spinal nerves leads to neurological dysfunction such as numbness, tingling, pain and stiffness in the neck and pain and numbness in the arms, fingers, or hands. Patients may experience muscular abnormalities including, but not limited to, problems with balance and walking, incoordination, muscle weakness in arms, shoulders, or hands, rhythmic muscle spasm, stiff muscles, loss of muscle, overactive reflexes, and loss of bladder and bowel control. Depending on the severity of symptoms, the options for treatment of DCM are a movement-restricting collar, physical therapy, pain relievers, muscle relaxants, and surgery. Currently, no cure exists and there is no approved medication to treat DCM.

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