NEW YORK, March 13, 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 it has
initiated dosing in the final patient in the Company's randomized,
double-blind, placebo-controlled, confirmatory Phase 2 clinical
trial of Bryostatin-1 in moderate to severe AD patients not on
memantine. A total of 108 patients were enrolled into the
study.
"Completion of enrollment in our confirmatory Phase 2 trial is
an important step toward understanding the transformative potential
of Bryostatin in moderate to severe Alzheimer's disease, a
neglected area of AD research with no effective treatment options,"
stated Dr. Daniel Alkon, President
and Chief Scientific Officer of Neurotrope. "Bryostatin uses a
novel, multi-modal mechanism of action which has demonstrated the
ability to generate new, mature synaptic connections and prevent
neuronal death in AD models. The promising data from our previous
exploratory Phase 2 trial showed greater than baseline improvements
in Severe Impairment Battery (SIB) scores for patients in the 20 µg
Bryostatin-1 dose group, suggesting the potential to translate
Bryostatin's neurorestorative properties in the clinic."
The current confirmatory Phase 2 multicenter trial is designed
to assess the safety and efficacy of Bryostatin-1 as a treatment
for cognitive deficits in 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.
"We believe that Bryostatin may have transformative potential as
a treatment for moderate to severe AD," stated Dr. Charles Ryan, Chief Executive Officer of
Neurotrope. "This confirmatory Phase 2 study could be a critical
point of validation for our Bryostatin platform. We look forward to
reporting top-line data from this study in the second half of 2019,
and to making continued progress in exploring Bryostatin's
potential in other disease indications."
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, 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. 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. The Company
does not undertake to update these forward-looking statements.
Contact information:
Investors
Tom Caden
Vice President
CORE IR
516 222 2560
tomc@coreir.com
www.coreir.com
Media
Jules Abraham
CORE IR
917 885 7378
julesa@coreir.com
View original
content:http://www.prnewswire.com/news-releases/neurotrope-completes-enrollment-of-confirmatory-phase-2-study-of-bryostatin-1-in-moderate-to-severe-alzheimers-disease-300811313.html
SOURCE Neurotrope Inc.