Sound Pharmaceuticals (SPI) will collaborate with the University of Oxford on a Phase 2 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 one percent of adults worldwide. Unfortunately, patients have relatively few treatment options, often involving drugs such as lithium, which has 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 where 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.
Sound CEO Jonathan Kil, MD, said: 'We are committed to testing our novel investigational drugs in human diseases where the unmet medical need has devastating societal impact.'
Professor Philip Cowen, Principal Investigator of the upcoming Oxford study is a distinguished clinician in the Department of Psychiatry who has received numerous awards for his ground breaking work on the psychopharmacology of complex mood disorders, such as bipolar disorder. The Department of Psychiatry, headed by Professor John Geddes, has a world-wide reputation for the investigation and treatment of bipolar illness Preliminary human trials of ebselen have been conducted in healthy volunteers at Oxford's Warneford Hospital.
Professor Cowen said: '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. The interest in ebselen as a lithium-mimetic comes from a discovery made in the University Department of Pharmacology by Dr Grant Churchill and colleagues that ebselen, like lithium, inhibits a key enzyme called inositol phosphatase, which is involved in cell signalling. This action is thought to be critical to the effects of lithium in bipolar disorder which suggests that ebselen, as a well tolerated and safe drug, might be a possible substitute treatment for lithium.'
As part of the collaboration, Isis Innovation, Oxford's technology commercialisation 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.