Major Depressive Disorder (MDD) afflicts about 15 million Americans and is the leading cause of disability in the U.S. for those aged 15-44, according to the National Institute of Mental Health. Although experiencing the blues is part of the human condition, MDD is more than just the sadness that accompanies misfortune. MDD is a chronic feeling of enervation, loss of interest in activities, pessimism and hopelessness. At one time regarded as caused by supernatural forces, today, modern medical science generally attributes depression to chemical imbalances in the brain. However, with its small-molecule benzylpiperazine-aminopyridine drug NSI-189, Neuralstem, Inc. (NASDAQ: CUR) has evolved a new approach to lifting the blues.
NSI-189 was developed as a result of the research, undertaken by Neuralstem, into neural stem cell lines from the human hippocampus. The hippocampus is a part of the brain involved in memory and the generation of new neurons. In a process referred to as neurogenesis, NSI-189 was shown to stimulate the generation of new neurons in vitro and in animal models. In phase Ib human clinical trials for MDD, NSI-189 demonstrated ‘clinically meaningful’ improvement across all depressive and cognitive measures.
This approach based on neurogenesis is a novel one. Current medications for depression generally attempt to modulate levels of different chemicals (neurotransmitters) in the brain. The most common type of such treatments is thought to be selective serotonin reuptake inhibitors (SSRIs).
In addition to the brain chemistry factors that cause depression, modern scholarship has uncovered a link between depression and the physiology of the brain. Those who suffer from chronic depression display reduced hippocampal volume. The healthy hippocampus, however, is a rich source of neural stem cells, from which new neurons are generated, making vital new connections throughout life. Neuralstem believes that stimulating the generation of new neurons in the hippocampus could potentially address the pathology of the depression itself.
Phase Ia trials, testing NSI-189 for use against MDD, kicked off in February 2011 and ended in October 2011. Healthy volunteers, unafflicted by depression, were tested with escalating single administration doses of NSI-189. Later, a similar trial was conducted for depression patients. In phase Ib, which commenced in June 2012 and ended in the fourth quarter of 2013, the safety of escalating doses of NSI-189 for 28 daily administrations in 24 patients suffering from MDD was tested.
At present, enrollment for a phase II trial has commenced. The trial, which is already 50 percent enrolled, is expected to yield top line results in the second half of 2017.
NSI-189 has had a colorful history. This feature in Bethesda magazine (http://dtn.fm/aRw8k) claims that NSI-189 stems from efforts by the Defense Advanced Research Projects Agency (DARPA), most famously home to the genesis of the internet, to cultivate ‘a “super soldier” who could stay awake and alert for a week at a time’. The contract was later cancelled and Neuralstem turned its attention to developing a remedy for the cell damage that can occur in the sleep-deprived hippocampus.
Neuralstem has the resources to expedite the clinical trial process. Through a recent agreement with the Tianjin Pharmaceutical Holding Group, the company has secured $20 million for completion of the phase II trial. This supplements the $11.1 million in cash on the balance sheet at the end of 2Q16.
In a report by Aegis Capital Corp. (http://dtn.fm/cZW0X), Neuralstem stock has been given a price target of $2.25. The share price on November 7 was $0.23. It seems that NSI-189 is lifting more than the blues.
For more information, visit www.neuralstem.com
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