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news.Neuralstem has begun dosing first patient in Phase Ib of its ongoing trial evaluating the safety of NSI-189 in the treatment of major depressive disorder (MDD).
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NSI-189, a proprietary new chemical entity, stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD as well as other diseases and conditions.
Neuralstem board director and chief scientific officer Karl Johe said the company begins testing the safety of NSI-189 in depression patients.
"We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source," Johe added.
The Ia phase of the double-blind, placebo-controlled NSI-189/MDD trial tested escalating doses of single administration of NSI-189 in healthy patients.
The Ib phase, which is expected to take six months to complete, will test the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients.