(dailyRx News) Neuralstem, Inc. has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to kick off two safety trials testing a major depression treatment.
The two- Phase I studies would test NSI-189, its first small-molecule compound, which stimulates new neuron growth in the hippocampus, a part of the brain thought to be involved in major depression.
Neuralstem President & CEO Richard Garr said he believes NSI-189 marks a major milestone in antidepressant therapy "based on a new mechanism of action that may, for the first time, fundamentally modify the disease."
The most commonly prescribed antidepressants today address serotonin (a neurotransmitter) deficiency, whereas NSI-189 appears to recruit neural stem cells to repair and protect the Central Nervous System. Newer theories suggest stress can lead to hippocampal atrophy (shrinkage) and inhibit growth of new neurons in the brain, which NSI-189 seeks to address.
The first trial, if approved, will involve healthy volunteers testing the safety and gradually increasing doses of NSI-189. The second trial would test the safety of escalating doses in depressed patients for 28 days. The entire Phase I trial is expected to last approximately one year, if approved by the FDA.