NEW YORK, July 25, 2018 /PRNewswire/ -- Neurotrope, Inc.
(NASDAQ: NTRP) today presented additional clinical results
from its recently completed Phase 2 trial demonstrating that
moderate-to-severe Alzheimer's disease (AD) patients treated with
20 µg Bryostatin-1 showed evidence of sustained improvement in
cognition compared with placebo in patients not on concomitant
memantine treatment, with a safety profile similar to placebo. The
data and comprehensive statistical analysis are being presented in
the Developing Topics Poster Presentation, "Significant
Cognitive Improvement with Bryostatin for Advanced Alzheimer's
Patients in the Absence of Memantine" at the Alzheimer's
Association International Conference 2018 in Chicago.
In preclinical studies Bryostatin-1 lowers beta amyloid levels
by the activation of natural enzymatic pathways in the brain such
as IDE, ECE and neprilysin. Bryostatin has also shown
synaptogenesis and prevention of neuronal death in extensive
pre-clinical studies by activating synaptic growth factors such as
BDNF, IGF and NGF. Further data analysis of the recent Phase 2
trial results showed that advanced AD patients show improvement
(> 6.0 points vs. placebo and baseline) in the Severe Impairment
Battery (SIB) even 30 days after all drug dosing has been completed
in patients not on memantine.
"Patients not on memantine treatment exhibited significant
cognitive improvement, at all time points tested during the trial,
as evidenced by the SIB scores, with an average of 6.1 point
improvement (p=0.012) over baseline and placebo," stated Dr.
Richard Thompson, Senior
Statistician, Bloomberg School of Public
Health, Johns Hopkins University. Dr. Thompson continued,
"Various sensitive, comparative analyses were also conducted and
resulted in consistent conclusions, including sustainability of the
treatment effect over time, even 30 days after all dosing was
completed."
In Neurotrope's previous Phase 2 trial of Bryostatin-1 for
moderate-to-severe AD patients, Severe Impairment Battery (SIB)
scores were consistently greater than baseline, indicating
improvement for patients treated with a specific dose regimen,
(20 µg protocol). The magnitude of this SIB increase
above baseline was much greater when a pre-specified
exploratory analysis separated out patients who were not on
standard of care memantine therapy. Patients not on memantine
treatment exhibited an improvement of 6.1 points over baseline and
placebo, in their SIB scores. This was confirmed using three
different comprehensive statistical analyses detailed in the poster
being presented. Patients dosed in the 20 µg group in
combination with memantine background therapy, and the patients on
placebo with donepezil background therapy, did not show an increase
above the baseline score on the SIB scale.
"Because of the impressive improvement in the patients treated
with the 20 µg dose of bryostatin who were not on memantine,
Neurotrope has made the conservative decision to launch a
confirmatory Phase 2 trial testing 100 moderate-to-severe AD
patients with the 20 µg dose of Bryostatin-1 in a 1:1 ratio versus
placebo. We are delighted to have initiated enrollment of the
study earlier this month," said Dr. Charles
Ryan, Neurotrope Chief Executive Officer.
Preclinical findings by other labs confirm that memantine would
likely block bryostatin's observed improvement in
cognition, due to their use of a shared cell signaling pathway.
Both memantine and bryostatin engage the same receptor, the
NMDA receptor. Memantine directly blocks the NMDA receptor. In
the absence of memantine, bryostatin activates PKC, causing
engagement of the NMDA receptor. These clinical study results
validate Neurotrope's proposed mechanism of action for bryostatin
and its expected effects at a neuronal level, further bolstering
the Company's clinical program and informing the development of a
pivotal trial protocol for Bryostatin-1 in moderate-to-severe AD
patients.
The poster presentation information and a link to the poster is
below.
Title
|
Significant
Cognitive Improvement with Bryostatin for Advanced
Alzheimer's
Patients in the Absence of Memantine (Poster presentation
Abstract #27295)
|
|
|
Developing Topics
Session:
|
P4-199:
|
|
Date/Time
|
Wednesday, July 25,
2018: 9:30 AM-4:15 PM CDT
|
|
Location Hall
|
F1 - McCormick
Place
|
|
Link to the poster
www.neurotropebioscience.com/wp-content/assets/NTRP
Presentation AAIC 2018.pdf
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/at-aaic-2018-neurotrope-presents-additional-clinical-results-showing-cognitive-improvement-in-phase-2-data-assessing-bryostatin-1-in-moderate-to-severe-alzheimers-patients-300686185.html
SOURCE Neurotrope, Inc.