clinical trialSound Pharmaceuticals (SPI) will collaborate with the University of Oxford on a Phase II clinical trial to test SPI-1005 for the treatment of bipolar disorder.

Bipolar disorder is a psychiatric illness that involves both periods of mania and depression, and affects approximately 1% of adults worldwide. Unfortunately, patients have relatively few treatment options, often involving drugs such as lithium, which have significant side-effects.

SPI-1005 is an oral drug that contains ebselen, which mimics and induces the activity of glutathione peroxidase (GPx) in the brain and inner ear. SPI-1005 is under clinical investigation in several otologic diseases in which GPx activity is reduced, including noise-induced hearing loss, chemotherapy induced ototoxicity and Meniere’s disease.

GPx activity is thought to be diminished in several psychiatric disorders, including bipolar, schizophrenia and autism, and neurologic diseases including traumatic brain injury, stroke, dementia and Parkinson’s. “We are committed to testing our novel investigational drugs in human diseases where the unmet medical need has devastating societal impact,” said Jonathan Kil, MD, CEO.

Dr Philip Cowen, Principal Investigator of the upcoming Oxford study is a distinguished clinician in the Department of Psychiatry. He has received numerous awards for his groundbreaking work on the psychopharmacology of complex mood disorders, such as bipolar disorder.

Preliminary human trials have been conducted in healthy volunteers at Oxford’s Warneford Hospital. “Based on the novel anti-inflammatory activity of ebselen, together with its lithium-like effects on signal transduction, we hope that it will benefit patients with bipolar illness,” said Dr Cowen. As part of the collaboration, Isis Innovation, Oxford’s technology commercialization arm has provided SPI with exclusive IP rights. The Stanley Medical Research Institute (SMRI), a leading funder of clinical trials involving psychiatric disease, is providing support for this study.

SPI is a privately held biotech in Seattle (WA, USA) developing the first drugs for the prevention and treatment of sensorineural hearing loss and tinnitus. SMRI is a non-profit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. SMRI has supported more than $550 million in research in over 30 countries.

Isis Innovation provides access to technology from Oxford researchers through intellectual property licensing, spinout company formation and material sales, and to academic expertise through Oxford University Consulting. Isis is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 110 new companies in 25 years.