Neuralstem Reports Last Subject Out in Phase 2 Trial of NSI-189 for Major Depressive Disorder
May 17 2017 - 4:05PM
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company
developing next generation treatments for nervous system diseases,
today announced it has completed dosing of the last subject in its
multicenter Phase 2 clinical trial evaluating the efficacy of
NSI-189 for the treatment of major depressive disorder (MDD).
NSI-189 is an oral antidepressant with a novel mechanism of
action and is the lead compound in Neuralstem's neurogenic small
molecule program.
“We believe that NSI-189 is a next generation
treatment for MDD as it has the potential to promote remodeling of
the hippocampus and reverse hippocampal atrophy, which has been
linked to MDD pathology. Our goal is to further understand
NSI-189’s role in MDD and believe that it may also have application
in additional indications that affect cognition and/or
neurodegeneration,” said Rich Daly, chairman and CEO,
Neuralstem. “We look forward to unblinding the study data and
analyzing the results. As previously announced, we anticipate
that the top line data will be available in the third quarter of
this year. We appreciate the enthusiasm of our
investigators and commitment by the subjects, which has allowed the
study to be completed approximately four months earlier than
planned.”
The Phase 2 clinical trial is a randomized,
double-blind, placebo-controlled study in 220 subjects with
MDD. Subjects were randomized and received 12-weeks of oral
treatment with NSI-189 40 mg twice daily (BID), NSI-189 40 mg once
daily (QD), or placebo in an outpatient setting. The primary
efficacy endpoint is a reduction in depression symptoms as
measured by the Montgomery-Asberg Depression Rating Scale
(MADRS). The study is 80% powered (p ≤ 0.05) to show an
improvement in depression symptoms, compared to placebo, with an
effect size of d=0.5.
NSI-189: Neuralstem’s Lead
AssetNSI-189 is a next-generation, first-in-class
compound. NSI-189 is in a Phase 2, double-blind,
placebo-controlled study for the treatment of major depressive
disorder (MDD). The study incorporates strategies to limit
placebo effect, and is designed to randomize 220 subjects in three
cohorts (two active doses plus placebo) at 12 select trial sites.
Dr. Maurizio Fava, Slater Family Professor of Psychiatry at Harvard
Medical School, Massachusetts General Hospital, is the principal
investigator. Top line results of the Phase 2 study are
expected four months ahead of schedule in the third quarter of
2017.
In a Phase 1B study in subjects with MDD, NSI-189
showed strong potential for efficacy on both depression and
cognition scales. Results from the study also indicated that the
compound may impart a durable effect. Data suggest that
NSI-189 works by promoting synaptogenesis or neurogenesis in the
hippocampus; a different mechanism of action than current marketed
antidepressants. NSI-189 may have broad utility as a
neuroregenerative drug.
About Neuralstem Neuralstem is a
clinical-stage biopharmaceutical company developing next-generation
treatments for nervous system diseases of high unmet medical
need. Neuralstem’s lead asset, NSI-189, is an oral
antidepressant in Phase 2 clinical development for major depressive
disorder (MDD). NSI-566 is a stem cell therapy being tested
in stroke, chronic spinal cord injury (cSCI) and Amyotrophic
Lateral Sclerosis (ALS). Neuralstem’s diversified portfolio
of product candidates is based on its proprietary neural stem cell
technology.
Cautionary Statement Regarding Forward
Looking InformationThis news release contains
“forward-looking statements” made pursuant to the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements relate to future, not past, events
and may often be identified by words such as “expect,”
“anticipate,” “intend,” “plan,” “believe,” “seek” or “will.”
Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Specific risks and
uncertainties that could cause our actual results to differ
materially from those expressed in our forward-looking statements
include risks inherent in the development and commercialization of
potential products, uncertainty of clinical trial results or
regulatory approvals or clearances, need for future capital,
dependence upon collaborators and maintenance of our intellectual
property rights. Actual results may differ materially from the
results anticipated in these forward-looking statements. Additional
information on potential factors that could affect our results and
other risks and uncertainties are detailed from time to time in
Neuralstem’s periodic reports, including the Annual Report on Form
10-K for the year ended December 31, 2015, and Form 10-Q for the
nine months ended September 30, 2016, filed with the Securities and
Exchange Commission (SEC), and in other reports filed with the SEC.
We do not assume any obligation to update any forward-looking
statements.
Contact:
Danielle Spangler
Director of Investor Relations, Neuralstem
301-366-1481
dspangler@neuralstem.com
Kimberly Minarovich
Argot Partners (Investor Relations)
212-600-1902
kimberly@argotpartners.com
Lori Rosen
LDR Communications (Public Relations)
917-553-6808
lori@ldrcommunications.com
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