NEW YORK, Sept. 9, 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 its
confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD
did not achieve statistical significance on the primary endpoint,
which was change from baseline to Week 13 in the Severe Impairment
Battery (SIB) total score.
An average increase in SIB total score of 1.3 points and 2.1
points was observed for the Bryostatin-1 and placebo groups,
respectively, at Week 13. There were multiple secondary outcome
measures in this trial, including the changes from baseline at
Weeks 5, 9 and 15 in the SIB total score. No statistically
significant difference was observed in the change from baseline in
SIB total score between the Bryostatin-1 and placebo treatment
groups.
"We are disappointed in the topline results from the
confirmatory Phase 2 study," said Dr. Charles S. Ryan, Neurotrope's Chief Executive
Officer. "Having just received the data, we are conducting a full
review to determine potential next steps and will provide an update
of our plans when appropriate. We sincerely thank the patients,
physicians, study coordinators and the entire Neurotrope team for
their support of this novel study."
About the Confirmatory Phase 2 Study
The confirmatory Phase 2 multicenter trial was 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 was the change in
the SIB score between the baseline and week 13. Secondary endpoints
included repeated SIB changes from baseline SIB at weeks 5, 9, 13
and 15.
About Neurotrope
Neurotrope is a clinical-stage biopharmaceutical company working
to develop novel therapies for neurodegenerative diseases,
including Alzheimer's disease (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 its
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 its 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 June 30, 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
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SOURCE Neurotrope, Inc.