NEW YORK, Aug. 13, 2018 /PRNewswire/ -- Neurotrope, Inc.
(NASDAQ: NTRP), a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), today provided a business
update outlining recent clinical development progress and other
noteworthy events that occurred subsequent to the end of the
quarter and unaudited financial results for the quarter ended
June 30, 2018.
Clinical Development Highlights
On July 17, 2018, Neurotrope
announced that it initiated enrollment of a confirmatory Phase 2
clinical trial in 100 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. Dosing has begun in
the study, and we are anticipating completion of the study sometime
during the third quarter of 2019. The study will be conducted
at approximately 30 clinical trial sites.
Corporate Announcements
On July 25, 2018 at the
Alzheimer's Annual International Conference (AAIC) 2018 in
Chicago, Neurotrope presented
comprehensively analyzed data from its recent Phase 2 clinical
trial. These new statistical data confirmed and extended
previous analyses that Bryostatin caused AD patients, not on
baseline memantine therapy, to improve more than 6.1 points over
baseline and placebo in their Severe Impairment Battery (SIB)
scores, in a pre-specified exploratory endpoint. This improvement
persisted at least 30 days after all dosing was completed, as was
confirmed with three different rigorous statistical analyses that
were presented. These new analyses, together with many
previous pre-clinical studies, suggest that Bryostatin can
contribute to the anti-amyloid and anti-tau pathways as targeted by
many other current company strategies, but may also uniquely engage
natural pathways with regenerative benefits for the degenerating
brain.
On July 11, 2018, the Company
announced the formation of a Scientific Advisory Board being
chaired by Dr. Martin Farlow,
MD. Other members of the esteemed board are: Drs. Paul Coleman
PhD; Daniel F Hanley Jr. MD; Marwan Subbagh, MD, and Lee Jen Wei, PhD.
"We believe that these Phase 2 study results presented at AAIC
2018 in July, suggest potential sustained clinical improvement not
previously reported for moderate to severe AD patients.
Extensive pre-clinical research suggested that Bryostatin not
only activates natural enzymes in the human brain to degrade
Amyloid beta and prevent abnormal tau, but we believe that it
also activates natural enzymes to promote synaptic growth and
prevent neuronal death. We believe that these multi-modal
enzymatic effects, that include activation of well-known
synaptic growth factors, may allow Bryostatin to not only
slow down the cognitive decline of the disease, but it may also
explain the increase in cognition" said Dr. Charles Ryan, Chief Executive Officer of
Neurotrope.
Second Quarter 2018 Financial Results (Unaudited)
As of June 30, 2018, the Company
had approximately $11.8 million of
cash and cash equivalents. The Company's only significant financial
commitments are the amounts due to Worldwide Clinical Trials for
the recently initiated Phase 2 clinical trial of up to
approximately $5.5 million. The
Company has sufficient capital to complete such confirmatory Phase
2 clinical trial.
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 June 30, 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)
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SOURCE Neurotrope, Inc.