40 mg dose showed statistically
significant improvement on Cogscreen objective cognitive measures
of attention and memory
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company
developing novel treatments for nervous system diseases, today
announced that additional safety, efficacy and tolerability data
from its exploratory Phase 2 clinical trial examining the efficacy
of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID)
compared to placebo for the treatment of major depressive disorder
(MDD) were presented at the 56th American College of
Neuropsychopharmacology (ACNP) Annual Meeting in a poster entitled,
“A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189
Phosphate, a Neurogenic Compound, Among Out-Patients with Major
Depressive Disorder.” These additional results suggest that
NSI-189 has antidepressant effects with cognitive benefits shown on
both objective and subjective measures.
“NSI-189 appears to be a broad-acting antidepressant, with
effects in both core symptoms of depression and in aspects of
cognition where standard antidepressants typically show very modest
effects. These results warrant the continued study of this
compound among MDD patients who are inadequately managed by current
antidepressant therapies,” said Maurizio Fava, MD, Director of the
Division of Clinical Research of the MGH Research Institute and
Executive Vice Chair, Department of Psychiatry at Massachusetts
General Hospital, and the principal investigator of the trial.
In the Phase 2 trial, 220 subjects were randomized to: NSI-189
40mg daily (n=44), NSI-189 80mg daily (n=44), or placebo (n=132)
for 6 weeks (Stage 1). At the end of 6 weeks, placebo-treated
subjects who were non-responders (defined as less than 50%
reduction in Montgomery-Asberg Depression Rating Scale (MADRS))
with a MADRS score greater than 15 were re-randomized to 6 weeks
treatment with NSI-189 40 mg daily (n=22), NSI-189 80 mg daily
(n=22), or placebo (n=22) (Stage 2). Patients on NSI-189 who
completed Stage 1 continued the same dose for another 6
weeks. The primary outcome measure was the MADRS.
Secondary outcome measures included the 17-item Hamilton Depression
Rating (HAMD-17), the Symptoms of Depression Questionnaire (SDQ),
the Cognitive and Physical Functioning Scale (CPFQ), the
patient-rated version of the Quick Inventory of Depressive
Symptomatology Scale (QIDS-SR), and CogScreen and CogState
objective cognitive tests. Efficacy results concerning all patients
randomized in Stage 1 were pooled (50:50 weighted average) with the
Stage 2 results of all re-randomized patients who had been
non-responders to placebo in Stage 1.
Using the Sequential Parallel Comparison Design (SPCD) pooled
analysis approach, MADRS score reduction from baseline with 40mg or
80mg NSI-189 versus placebo did not reach statistical significance
(mean difference -1.8, p=0.22, mean difference -1.4, p=0.34,
respectively). However, the 40 mg dose resulted in a
statistically significant reduction in SDQ (mean difference -8.2,
p=0.04), and CPFQ scores (mean difference -1.9, p=0.03) versus
placebo in the pooled SPCD analyses. There was also a statistically
greater reduction in QIDS-SR scores versus placebo for patients
treated with 40 mg of NSI-189 in Stage 2 (-2.5, p=0.04), but not
Stage 1. Differences for the 80 mg dose versus placebo on
these three self-report measures were not statistically
significant.
In addition, the 40mg dose also showed statistical advantages on
objective measures of attention and memory as per the Cogscreen
test, but not the Cogstate test: Simple Attention (SATADRTC,
p=0.034; Complex Attention (SATACACC, p = 0.048) and Memory
(SDCDRACC, p = 0.002; also seen with 80mg dose, p = 0.015).
Both doses were well-tolerated with 0, 0 and 7 subjects
discontinuing treatment with 40mg, 80mg and placebo, respectively,
due to intolerance in Stage 1, and 1,0 and 1 subjects discontinuing
treatment with 40mg, 80mg and placebo, respectively, due to
intolerance in Stage 2. Furthermore, no subjects treated with
NSI-189 experienced a serious adverse event during the study.
“We are extremely pleased that the novel, neurogenic,
neurotrophic mechanism of action of NSI-189 has shown both
antidepressant and pro-cognitive activity in depressed patients,
and which appears to result in meaningful benefit as reported both
by the patients themselves and by objective computerized
measurements. These results further support those from the
previous Phase 1b in subjects with MDD, which demonstrated
potential efficacy on both depression and cognition scales. We look
forward to meeting with the Food and Drug Administration (FDA) in
the first half of 2018 to further define the clinical development
and regulatory paths for NSI-189, as well as to submit the results
of this study to a peer reviewed publication by the end of this
year,” said Rich Daly, Chairman and CEO, Neuralstem.
Conference Call and WebcastIn connection with
this announcement, Neuralstem will host a conference call today,
Tuesday, December 5, at 8:30 a.m. ET. The call can be accessed by
dialing 1 (833) 584-0034 (U.S. and Canada) or 1 (409) 350-3602
(international). The conference ID number is 4382159. To access the
live webcast, or the subsequent archived recording, visit the
"Events" section of the Neuralstem website at www.neuralstem.com.
An archived presentation will be available for 90 days.
About NSI-189
NSI-189, a benzylpiperazine-aminopyridine, is a small molecule
in clinical development for MDD and in preclinical development for
Angelman syndrome, irradiation-induced cognitive impairment, Type 1
and Type 2 diabetes, and stroke. NSI-189 is a novel compound
developed for the treatment of MDD. Data suggest that NSI-189 works
by promoting synaptogenesis or neurogenesis in the hippocampus; a
different mechanism of action than currently marketed
antidepressants. Based on preclinical studies, NSI-189 has
shown to stimulate neurogenesis of human hippocampus-derived neural
stem cells in vitro and stimulates neurogenesis in mouse
hippocampus in vivo. These studies suggest that NSI-189 may have
broad utility as a neuroregenerative drug. NSI-189 was
discovered using the Company’s stem cell-based screening platform.
The Company’s portfolio of small molecule compounds, which includes
NSI-189, are covered by 10 U.S. exclusively owned issued and
pending patents and over 60 exclusively owned foreign issued and
pending patents.
About Neuralstem Neuralstem is a clinical-stage
biopharmaceutical company developing novel treatments for nervous
system diseases of high unmet medical need. NSI-189 is a
small molecule in clinical development for major depressive
disorder (MDD) and in preclinical development for Angelman
syndrome, irradiation-induced cognitive impairment, Type 1 and Type
2 diabetes, and stroke. NSI-566 is a stem cell therapy being
tested for treatment of paralysis 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, 2016, and Form 10-Q for the three and nine
months ended September 30, 2017, 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:
Kimberly MinarovichArgot Partners (Investor
Relations)212-600-1902kimberly@argotpartners.com
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