NEW YORK, Jan. 22, 2020 /PRNewswire/ -- Neurotrope,
Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company"), a
clinical-stage biopharmaceutical company developing novel therapies
for neurodegenerative diseases, today announced its corporate
update.
The Company has completed analysis of the data (Clinical Study
Report) from its recently reported Phase 2 confirmatory clinical
trial (the "203 study"), examining moderately severe to severe
Alzheimer's disease patients treated with Byrostatin-1 in the
absence of memantine / Namenda.
"A significant imbalance (4.8 points) in the baseline Severe
Impairment Battery ("SIB") scores occurred, by chance, between the
Bryostatin-1 treatment group and placebo group," stated Dr.
Daniel Alkon, Neurotrope's President
and Chief Scientific Officer. "After consulting with our
Scientific Advisory Board and statistical experts, we were advised
that, in a small study such as this, a baseline imbalance could
prevent a definitive analysis of Bryostatin-1 treatment versus
placebo in SIB scores at the primary (Week #13) and secondary
endpoints as provided in the original Statistical Analysis Plan
("SAP")," stated Dr. Alkon.
"Due to the baseline imbalance observed in the study, and
because a clear signal of benefit could be observed in the raw data
from the pre-specified Moderate Stratum, we conducted a
post-hoc analysis using paired data for individual patients, with
each patient as his/her own control," stated Kazem Kazempour, Chief Executive Officer of
Amarex, Inc., the biostatistician retained to analyze the data from
the 203 study under the SAP. For the pre-specified Moderate
Stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value
and the week 13 value were used, resulting in pairs of observations
for each patient. The changes from baseline for each patient were
calculated and a paired t-test was used to compare the mean
change from baseline to week 13 for each patient. A total of
65 patients had both baseline and week 13 values, from
which there were 32 patients in the Bryostatin-1
treatment group and 33 patients in the placebo group. There
was a statistically significant improvement over baseline (4.8
points) in the mean SIB at week 13 for subjects in the Bryostatin-1
treatment group (32 subjects), paired t-test p < 0.0076,
2-tailed.
In the placebo group (33 subjects), there was also a
statistically significant increase from baseline in the mean SIB at
week 13, for paired t-test p < 0.0144, consistent with the
placebo effect seen in the overall 203 study. "This smaller,
placebo effect could possibly be due to the imbalance observed even
for the Moderate Stratum in the study," stated Dr. Alkon. For
the pre-specified Severe Stratum (MMSE-2 baseline scores 4 – 9)
patients, there was no statistically significant change from
baseline for either the treatment or the placebo group.
As a further test of the robustness of this Moderate Stratum
benefit signal, a pre-specified trend analysis (measuring increase
of SIB improvement as a function of successive drug doses) was
performed on the repeated SIB measures over time (Weeks 0, 5, 9,
and 13). These trend analyses showed a significant positive
slope of improvement for the treatment groups in the 203 study that
was significantly greater than for the placebo group
(p<.01).
The Company is pleased to announce that it has been awarded
$2.7 million from the National
Institute of Health ("NIH") to support an additional Phase 2
clinical study focused on the Moderate Stratum for which the
Company saw improvement in the 203 study. Neurotrope looks
forward to working with the NIH on the continuation of the
Bryostatin program. The Company is planning to meet with the
Food and Drug Administration to present the totality of the
clinical program data for Bryostatin-1 (NTRP101-202 and
NTRP101-203).
"I am encouraged by the NIH funding," stated Dr. Marwan Sabbagh, Director, Cleveland Clinic Lou Ruvo Center for Brain
Health, and advisor on the design of the 203 trial.
"The data suggests that Bryostatin may still be considered a new
approach to Alzheimer's treatment." Dr. Sabbagh is also a
paid member of the Company's Scientific Advisory Board.
Neurotrope continues to review several viable strategic
alternatives. "We are continuing our efforts to identify the
most favorable strategic alternative for the Company," stated
Charles S. Ryan, Neurotrope's Chief
Executive Officer. "The Committee has been working tirelessly in an
effort to increase shareholder value. We are pleased with the
progress that has been made and expect to provide additional
guidance in the near future."
About Neurotrope
Neurotrope is a clinical-stage biopharmaceutical company working
to develop novel therapies for neurodegenerative diseases.
Neurotrope has conducted clinical and preclinical studies of its
lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease,
and preclinical studies 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 Company's plans to explore strategic alternatives and
the potential outcome and benefits of a potential strategic
transaction, 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 Company will be
able to identify potential strategic transactions and complete any
transactions it may pursue or realize the expected benefits from a
strategic review or a strategic transaction, 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 identify potential strategic transactions
and to complete any transactions it pursues, 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 September 30, 2019. The Company does not
undertake to update these forward-looking statements.
Contact information:
Robert Weinstein
Chief Financial Officer
Email: rweinstein@neurotrope.com
Phone: 973.242.0005 Ext.101
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SOURCE Neurotrope, Inc.