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Neuralstem Pharmaceuticals
for Major Depressive Disorder

  • Product status: NSI-189 Phase I safety trial in final phase: Ib, depression patients
  • Mechanism of Action: Stimulating neurogenesis
  • Route of Administration: Oral

Most current major depressive disorder (MDD) treatments are oral medications that modulate levels of different neurotransmitters in the brain. One class, selective serotonin reuptake inhibitors (SSRIs), is commonly believed to be the most widely-prescribed type of antidepressants in the world.

However, a new theory on major depressive disorder is emerging. It implicates brain physiology in the disease rather than brain chemistry alone. Researchers now know that depressed patients have reduced hippocampal volume. The healthy hippocampus 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.

Neuralstem’s NSI-189 Major Depressive Disorder Trial

The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of major depressive disorder. Phase Ia, initiated in February 2011 and completed in October 2011, tested escalating doses of single administration of NSI-189 in healthy normal volunteers. Phase Ib, approved by the FDA in December 2011 and commenced in June 2012, tests the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients. The FDA approved dosing of the third and final cohort of depression patients in April 2013. Neuralstem is expected to complete the entire Phase I NSI-189/MDD trial in the third quarter of 2013.

In preclinical work, Neuralstem’s lead pharmaceutical compound, NSI-189, demonstrated clear evidence of increased hippocampal volume in animals with a model of depression. Neuralstem believes NSI-189 has the potential to reverse the hippocampal atrophy associated with major depressive disorder and other related disorders, and to restore fundamental brain physiology.

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Major depressive disorder is characterized by a combination of symptoms that interferes with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. It is disabling and prevents a person from functioning normally. An episode of major depressive disorder may occur only once in a person's lifetime, but more often it recurs throughout a person's life. Major depressive disorder affects approximately 14.8 million American adults and is the leading cause of disability in the U.S. for ages 15-44, according to the National Institute of Mental Health.