NEW YORK, July 15, 2019 /PRNewswire/ -- Neurotrope Inc.
(Nasdaq: NTRP), a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), today announced that the
Company has concluded data collection in its confirmatory Phase 2
double blind, placebo controlled clinical trial of Bryostatin-1 in
the treatment of moderately severe to
severe AD.
Data from the previous exploratory Phase 2 trial demonstrated
clear safety and showed greater than baseline improvements in
Severe Impairment Battery (SIB) scores that were sustained for
patients in the 20µg Bryostatin-1 dose group not on memantine. The
current confirmatory Phase 2, multi-center trial is designed to
assess the safety and efficacy of Bryostatin-1 as a treatment for
cognitive deficits in 108 patients with moderate to severe AD,
defined as a Mini Mental State Exam 2 score of 4 - 15, who are not
currently taking memantine. Patients were randomized 1:1 to be
treated with either Bryostatin-1 20μg or placebo, receiving 7 doses
over 12 weeks. Patients on memantine, an NMDA receptor
antagonist, were excluded unless they had been discontinued from
memantine treatment for a 30-day washout period prior to study
enrollment. The primary efficacy endpoint is the change in
the SIB score between the baseline and week 13. Secondary endpoints
include repeated SIB changes from baseline SIB at weeks 5, 9, 13
and 15.
"Prior animal studies have demonstrated bryostatin's potential
for restorative synaptogenesis, prevention of neuronal death,
anti-inflammation, anti-amyloid, and anti-hyperphosphorylation of
tau via the activation of PKC epsilon. This multi-modal activity could potentially
distinguish Bryostatin-1 from previously tested drug candidates
that predominantly targeted amyloid plaque or tau neurofibrillary
tangles," stated Dr. Daniel L.
Alkon, Neurotrope's President and Chief Scientific Officer.
"The loss of synaptic networks, potentially addressed by
bryostatin, has been found in certain studies to correlate with the
severity of cognitive dysfunction and disease progression."
"We believe that bryostatin could possibly have transformative
potential as a treatment for moderate to severe AD," said Dr.
Charles S. Ryan, Neurotrope's Chief
Executive Officer. "We look forward to reporting
top-line data from this study during the third quarter of 2019,
which could be a critical point of validation for our bryostatin
platform."
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-1 as a potential treatment for rare diseases and brain
injury, including Fragile X syndrome, multiple sclerosis, stroke,
Niemann-Pick Type C disease, Rett syndrome, and traumatic brain
injury. The FDA has granted Orphan Drug Designation to Neurotrope
for Bryostatin-1 as a treatment for Fragile X. 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.
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 AD 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. 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 Securities and Exchange Commission, including the
Company's Annual Report on Form 10-K for the year
ended December 31, 2018, and on Form 10-Q for the quarter
ended March 31, 2019. The Company does not undertake to update
these forward-looking statements.
Contact information:
Public Relations
Susan Roberts
sr@roberts-communications.com
202-779-0929
Investors and Media
Contact information:
Investors and Media
Sam Martin and Ryan Baker
Argot Partners
212-600-1902
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SOURCE Neurotrope, Inc.