BrainCells Inc, a company leading the scientific research of neurogenesis using its proprietary neural stem cell platform technology to identify novel compounds for the treatment of central nervous system (CNS) diseases, has received the US patent which gives it coverage for treating depression with buspirone, a 5HTR agent, in combination with melatonin, by way of stimulating the formation of new nerve cells, or neurogenesis. Buspirone and melatonin are the two active agents in BCI-952, a compound that was selected by BrainCells’ platform and that demonstrated proof-of-concept in a clinical study.
The United States Patent and Trademark Office (US PTO) has issued the company, Patent Number 7,678,808 entitled, “5 HT Receptor Mediated Neurogenesis”. “This patent marks an important step in our development of BCI-952 for Major Depressive Disorder,” said Jim Schoeneck, CEO at BrainCells. “It covers the combination of a 5HTR compound with another agent at any synergistic level, giving our scientists the flexibility to develop BCI-952 at an optimum dose. Once the oral formulation of the buspirone-melatonin combination is complete, we plan to initiate clinical studies to confirm the effectiveness of BCI-952.”
Results from the six week proof-of-concept clinical study of BCI-952 showed that it had a positive clinical impact on depression symptoms with improvements in multiple clinical endpoints of depression including the Clinical Global Impressions Scale for improvement (CGII), the Inventory of Depressive Symptoms (IDSC30), the Hamilton Anxiety Scale and the patientrated Quick Inventory of Depressive Symptomatology (QIDS SR-16) as compared to placebo or buspirone alone. BCI-952 was also well tolerated, with a safety profile similar to placebo.