- Phase 2 Data Now Expected Ahead of
Schedule in 3Q 2017 -
Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused
on the development of central nervous system therapies based on its
neural stem cell technology, today announced completion of subject
enrollment in its Phase 2 clinical trial of NSI-189 for the
treatment of major depressive disorder (MDD). NSI-189 is a
new chemical entity and the lead compound in Neuralstem's
neurogenic small molecule program. Enrollment was completed
ahead of schedule and data are expected in 3Q 2017.
“Completing the last subject enrolled in the Phase 2 study with
NSI-189 for the treatment of MDD earlier than expected is a
significant clinical development milestone for Neuralstem,” said
Rich Daly, Chairman and CEO, Neuralstem. “We now expect
results from the Phase 2 study in the 3Q of 2017, and results from
the subsequent, 6-month observational study to assess NSI-189’s
durability effect will be available in the first half of 2018. We
are thankful to the individuals and physicians who are
participating in these studies and helping us to move closer to
potentially bringing this new category of treatment forward.”
The double-blind, placebo-controlled Phase 2 study randomized
220 subjects to one of three oral treatment groups: placebo,
40 mg once daily (QD), 40 mg twice daily (BID). The primary
efficacy endpoint is a reduction in depression symptoms as
measured by the Montgomery-Asberg Depression Rating Scale
(MADRS). Secondary endpoints encompass additional clinical
outcomes including objective cognition improvement measures.
The trial is evaluating subjects over a 12-week dosing period with
an observational follow-up period of six months to assess NSI-189's
potential for durability of benefits after the cessation of
therapy. The trial is being conducted in 12 select MDD trial
sites across the United States.
“Our goal is to improve the success rate in the treatment of
major depressive disorder, and fulfill the unmet medical need for
effective and well tolerated therapies that work differently from
antidepressants that are currently available,” said Maurizio Fava,
MD, Slater Family Professor of Psychiatry at Harvard Medical
School, Massachusetts General Hospital and principal
investigator. “The Phase 1 data have shown that NSI-189’s
biological mechanism of action may provide an alternative for the
treatment of MDD, with the potential for cognitive benefits and
durability effects beyond the course of treatment.”
NSI-189 is a proprietary, new chemical entity that has shown to
safely alleviate depression in a Phase 1b study with MDD
patients. In preclinical models, NSI-189 stimulated
neurogenesis, synaptogenesis and increased hippocampal volume, all
of which are believed to be effective in potentially reversing
depression, enhancing cognition, and promoting
neuroregeneration.
About the TrialThis Phase 2 double-blind,
placebo-controlled study is testing NSI-189 in a study of 220
subjects with MDD in an out-patient setting. Inclusion criteria
required subjects to have a MADRS score of 20 or greater at
screening and baseline. For context, a total MADRS score of
20 to 34 is suggestive of moderate depression while a score of 35
or greater is suggestive of severe depression.
Subjects were randomized to three cohorts: NSI-189 40 mg twice
daily (BID), NSI-189 40 mg once daily (QD), or placebo. After the
initial screening period, the randomized portion of the trial will
be 12 weeks in duration.
Subjects are being evaluated along several depression
measurement scales, including the MADRS, Symptoms of Depression
Questionnaire (SDQ) and the Hamilton Depression Rating Scale
(HAM-D), among others. 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. Subjects will continue to be
followed for an additional six months after the 12-week trial
period.
About Neuralstem Neuralstem’s patented
technology enables the commercial-scale production of multiple
types of central nervous system stem cells, which are being
developed as potential therapies for multiple central nervous
system diseases and conditions.
Neuralstem’s technology enables the generation of small molecule
compounds by screening hippocampal stem cell lines with its
proprietary systematic chemical screening process. The
screening process has led to the discovery and patenting of
molecules that Neuralstem believes may stimulate the brain’s
capacity to generate new neurons, potentially reversing
pathophysiologies associated with certain central nervous system
(CNS) conditions.
The company has completed Phase 1a and 1b trials evaluating
NSI-189, a novel neurogenic small molecule product candidate, for
the treatment of major depressive disorder or MDD, and is currently
conducting a Phase 2 efficacy study for MDD.
Neuralstem’s stem cell therapy product candidate, NSI-566, is a
spinal cord-derived neural stem cell line. Neuralstem is currently
evaluating NSI-566 in three indications: stroke, chronic spinal
cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).
Neuralstem is conducting a Phase 1 safety study for the
treatment of paralysis from chronic motor stroke at the BaYi Brain
Hospital in Beijing, China. In addition, NSI-566 was
evaluated in a Phase 1 safety study to treat paralysis due to
chronic spinal cord injury as well as a Phase 1 and Phase 2a risk
escalation, safety trials for ALS. Subjects from all three
indications are currently in long-term observational follow-up
periods to continue to monitor safety and possible therapeutic
benefits.
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
Investor Relations
Neuralstem, Inc
301.366.1481
Lori Rosen
Public Relations
LDR Communications
917.553.6808
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