NEW YORK, July 16, 2018 /PRNewswire/ -- Neurotrope
Inc. (NASDAQ: NTRP) a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), is announcing that the
first patient has been enrolled into its confirmatory Phase 2
clinical trial with its lead Alzheimer's disease drug,
Bryostatin-1. Patient recruitment will take place at
approximately 30 clinical sites in the
United States. This follow-on confirmatory clinical trial is
planned to include 100 patients with moderate to severe AD
(defined as a Mini Mental State Exam 2 score of 4-15).
Patients will be randomized 1:1 to be treated with either
Bryostatin-1 20ug or placebo, receiving 7 doses over 12
weeks. Patients on memantine, an NMDA receptor antagonist,
will be excluded unless they have been discontinued from memantine
treatment for a 30-day washout period prior to study
enrollment. The primary efficacy endpoint is the change in
the Severe Impairment Battery (SIB) score between the baseline and
the average of weeks 13 and 15. In our previous Phase 2
trial, patients in the bryostatin 20ug dose group not receiving
concurrent memantine treatment exhibited a SIB score improvement
from baseline of over 6 points. There was no corresponding
treatment effect for memantine-treated patients. Both
bryostatin and memantine, an N-Methyl-D-aspartate (NMDA) receptor
antagonist, engage the NMDA receptor. This convergence
of memantine and PKC on the NMDA receptor may explain why
patients who were not taking memantine during the trial
exhibited a consistent cognitive improvement as measured by the
SIB. In the absence of memantine, which blocks the NMDA
receptor, bryostatin-activated PKC epsilon contributes to
the regulation of this receptor.
"The potentially important persistence of the bryostatin-induced
improvement in the SIB scores in our recently completed Phase 2
trial, even one month after completion of all dosing, is an effect
that we hope to repeat in this confirmatory trial.
Immunologic A Beta degradation has recently been the target of
Biogen trials that appear to reduce the rate of cognitive decline
in prodromal and early AD patients. Bryostatin's mechanism
also contributes to the elimination of A Beta oligomers and
amyloid plaques through activation of brain A Beta degradation
enzymes. In addition, we believe the persistent reversal
of cognitive decline in advanced AD patients may result from the
multi-modal efficacies of bryostatin that include growth of new
synapses and prevention of neuronal death. In
late-stage AD patients in our Phase 2 trial, bryostatin appeared to
cause an increase in cognition – i.e. sustained improvement of SIB
scores over baseline. Bryostatin's sustained cognitive
improvement is consistent with a long-lasting consequence of
PKC epsilon-growth factor effects that could induce the growth
and/or maturation of synaptic networks in the brain. Our hope
is that this might translate into long lasting cognitive function
benefit in advanced AD patients, and earlier stage patients," said
Dr. Daniel Alkon, Neurotrope's
President and Chief Scientific Officer.
"Since February 2018, when I
joined Neurotrope, I have reviewed a more extensive data set from
the previous Phase 2 trial that gives me even more confidence that
bryostatin had a positive effect on the patients in that
study. I have also been receiving very positive feedback from
key opinion leaders and I am very encouraged that this confirmatory
Phase 2 study is initiating," said Dr. Charles Ryan, Chief Executive Officer of
Neurotrope.
About Neurotrope
Neurotrope is at the forefront of developing a new approach to
combating AD and other neurodegenerative diseases. The
Company's world-class science offers the potential to realize a
paradigm shift to overcome one of today's most challenging clinical
problems — finding a way to slow or even prevent the progression of
AD.
In addition to the Company's Phase 2 trial of Bryostatin-1 in
advanced AD, Neurotrope has also conducted preclinical studies of
bryostatin as a potential treatment for Stroke, Traumatic Brain
Injury, and Fragile X Syndrome, Niemann-Pick Type C disease and
Rett Syndrome—rare genetic diseases for which only symptomatic
treatments are currently available. The FDA has granted Orphan Drug
Designation to Neurotrope for Bryostatin-1 as a treatment for
Fragile X Syndrome. Bryostatin-1 has already undergone testing
in more than 1,500 people in cancer studies, thus creating a large
safety data base that will further inform clinical trial designs in
AD.
Please visit www.neurotrope.com for further
information.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. These forward-looking statements include statements
regarding the Phase 2 study and further studies, and continued
development of use of Bryostatin-1 for Alzheimer's dementia and
other cognitive diseases. Such forward-looking statements are
subject to risks and uncertainties and other influences, many of
which the Company has no control over. These statements are subject
to the risk that further analyses of the Phase 2 data may lead to
different interpretations of the data than the analyses conducted
to date and/or may identify important implications of the Phase 2
data that are not reflected in these statements. Clinical trial
data are subject to differing interpretations, and regulatory
agencies, medical and scientific experts and others may not share
the Company's views of the Phase 2 data. There can be no assurance
that the clinical program for Bryostatin-1 will be successful in
demonstrating safety and/or efficacy that we will not encounter
problems or delays in clinical development, or that Bryostatin-1
will ever receive regulatory approval or be successfully
commercialized. Actual results and the timing of certain events and
circumstances may differ materially from those described by the
forward-looking statements as a result of these risks and
uncertainties. Additional factors that may influence or cause
actual results to differ materially from expected or desired
results may include, without limitation, the Company's inability to
obtain adequate financing, the significant length of time
associated with drug development and related insufficient cash
flows and resulting illiquidity, the Company's patent portfolio,
the Company's inability to expand the Company's business,
significant government regulation of pharmaceuticals and the
healthcare industry, lack of product diversification, availability
of the Company's raw materials, existing or increased
competition, stock volatility and illiquidity, and the
Company's failure to implement the Company's business plans or
strategies. These and other factors are identified and described in
more detail in the Company's filings with the SEC, including the
Company's Annual Report on Form 10-K for the year
ended December 31, 2017, and on Form 10-Q for the quarter
ended March 31, 2018. The Company
does not undertake to update these forward-looking statements.
Contact information:
Investors and Media
Jeffrey Benison, Director of Corporate Communications
Neurotrope, Inc.
516.286.6099 (C) or 212.334.8709 (O)
jbenison@neurotrope.com
View original
content:http://www.prnewswire.com/news-releases/neurotrope-announces-the-initiation-of-enrollment-of-its-confirmatory-phase-2-trial-in-alzheimers-disease-300681010.html
SOURCE Neurotrope, Inc.