NEW YORK, Aug. 5, 2019 /PRNewswire/ -- Neurotrope, Inc.
(Nasdaq: NTRP), a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), today provided an update on
clinical and corporate developments, including its ongoing
confirmatory Phase 2 study of Bryostatin-1 in moderate to severe
AD, and announced financial results for the second quarter ended
June 30, 2019.
"The promising data from our previous exploratory Phase 2 trial
showed significant improvements in Severe Impairment Battery (SIB)
scores for patients in the 20µg Bryostatin-1 dose group not on
memantine, an NMDA antagonist. These results may indicate a
potential reversal of disease progression in patients with moderate
to severe AD, suggesting the potential to translate Bryostatin's
neurorestorative properties into the clinic. We look forward to
reporting top-line data from our confirmatory Phase 2 study during
the third quarter of 2019, and to moving bryostatin forward in the
clinic," stated Dr. Charles S. Ryan,
Neurotrope's Chief Executive Officer.
Dr. Daniel Alkon, Neurotrope's
President and Chief Scientific Officer, stated: "Our confirmatory
Phase 2 trial is based on compelling clinical data that was
recently published in the Journal of Alzheimer's
Disease.1 Bryostatin regulates the
NMDA receptor through PKC activation. Thus, the concurrent
use of an NMDA antagonist, which inhibits activity at the receptor,
may block the beneficial effects of bryostatin a potential
eliminated from the current trial design. Moreover, the consistency
observed in 94% of those patients not taking memantine further
supports our current study and underscores the transformative
potential of bryostatin as a treatment for AD."
Dr. Marwan Sabbagh, Director of
the Cleveland Clinic Lou Ruvo Center for Brain Health and member of
Neurotrope's Scientific Advisory Board, noted: "Bryostatin has a
novel mechanism of action, restoring synaptic networks, with some
encouraging data published earlier this year. I believe that
positive results from the current study would be a significant
advancement for patients with moderate to severe Alzheimer's
Disease. I look looking forward to seeing the results of the
Confirmatory Phase 2 study in the near future."
Clinical Development Highlights
- On July 15, 2019, Neurotrope
concluded data collection in its confirmatory Phase 2 double blind,
placebo controlled clinical trial of Bryostatin-1 in the treatment
of patients with moderately severe to severe AD who are not
currently taking memantine. Previously, on March 13, 2019, the Company announced dosing of
the final patient in the study. A total of 108 patients were
enrolled into the study, and top-line data is expected during the
third quarter of 2019.
Corporate Announcements
- In early April 2019, Neurotrope
appointed Dr. Michael Ciraolo as
general counsel and chief operating officer.
Second Quarter 2019 Financial Results (Unaudited)
As of June 30, 2019, the Company
had approximately $21.2 million of
cash and cash equivalents. The Company estimates that,
contingent upon future product development plans, it has sufficient
capital to fund operations through at least the next two years.
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 U.S. Food and Drug Administration 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.
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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2019. The Company does not undertake to
update these forward-looking statements.
Contact information:
Investors and Media
Sam Martin and Ryan Baker
Argot Partners
212-600-1902
Public Relations
Susan Roberts
sr@roberts-communications.com
202-779-0929
1 Farlow, M., Thompson, R. E., Wei,
L. J., Tuchman, A. J., Grenier, E., Crockford, D., ... Moreira, P.
(2019). A randomized, double-blind, placebo-controlled, phase
II study assessing safety, tolerability, and efficacy of bryostatin
in the treatment of moderately severe to severe Alzheimer's
disease. Journal of Alzheimer's
Disease, 67(2),
555-570. https://doi.org/10.3233/JAD-180759
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SOURCE Neurotrope, Inc.