NEW YORK, Oct. 6, 2020
/PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) today announced
dosing of the first patient in its ongoing, long-term Phase 2 study
of Bryostatin-1 for the treatment of Alzheimer's disease ("AD").
The study will be conducted in collaboration with the National
Institutes of Health ("NIH") under a $2.7
million grant to Neurotrope.
The new Phase 2 clinical study, which is expected to enroll
approximately 100 patients, will evaluate Bryostatin-1 in the
absence of Namenda® (memantine) for a six-month period, which will
include two 11-week dosing cycles. The study will focus on AD
patients with pre-specified moderately severe (Moderate Stratum;
MMSE-2 baseline score 14-10) and moderate (MMSE-2 baseline score
18–15) disease, including a patient population that demonstrated
the most evidence of benefit in a prior study, and will focus on
assessing sustained cognitive benefit as measured by the Severe
Impairment Battery ("SIB") score, a widely accepted measure of
cognitive function in advanced dementia patients.
Analysis of the data will be conducted in consultation with Dr.
Richard Thompson, Senior Scientist
from the Bloomberg School of Public Health at Johns Hopkins
University.
"After reviewing data from previous trials of Bryostatin-1 with
both key opinion leaders and the NIH, we determined that a study to
evaluate its long-term therapeutic effects in the absence of
Namenda® in patients with AD was a priority," stated Dr.
Daniel Alkon, President and Chief
Scientific Officer of Neurotrope. "We have made rapid progress in
commencing this study, and are very pleased to announce today that
the first patient has been dosed after significant progress in
patient enrollment. Among its potential effects, bryostatin has
been shown, pre-clinically, to reverse damage to the synaptic
connections between neurons that occurs in AD patients. AD
remains among the most significant public health challenges of our
modern era and, with support from the NIH, we hope to deliver
progress toward advancing a new and innovative, disease modifying
treatment."
This Phase 2 study is supported by Phase 2 clinical data from a
completed pilot trial (NTRP101-202) which evaluated Bryostatin-1 in
the absence of Namenda® in a short-term, 11-week treatment
protocol. In this prior study, Bryostatin-1 (20 mcg) was well
tolerated and showed early signals of cognitive benefit, including
improvement of 5.0 points in SIB score compared to baseline in the
Moderate Stratum cohort in the non-Namenda® group. This SIB
score improvement was sustained throughout the treatment period and
persisted for four weeks following completion of treatment. A
second pilot trial (NTRP101-203) using the same treatment protocol
(Bryostatin-1 in the absence of Namenda® for 11 weeks) showed a
similar SIB improvement compared to baseline for the Moderate
Stratum cohort.
We believe that the Neurotrope therapeutic strategy is a
first-in-class for the potential regeneration of synapses lost in
neurodegenerative diseases such as AD, Multiple Sclerosis and
Fragile X mental retardation. The signals of cognitive
benefit observed during our Bryostatin-1 pilot trials were
sustained over several weeks and, thus, may indicate the generation
of new synapses in pre-clinical models caused by the activation of
the PKC epsilon – BDNF (brain derived nerve factor) pathways by
bryostatin and related compounds in the Neurotrope platform.
"We believe that Neurotrope's proprietary platform holds
potential for developing treatments for Alzheimer's and other major
neurological diseases," stated Josh
Silverman, Chairman of the Board of Neurotrope. "Dosing the
first patient in our Phase 2 study of Bryostatin-1 in AD is an
important milestone for Neurotrope, and we remain grateful for the
ongoing support and validation from the National Institute on Aging
at the NIH. We also appreciate the ongoing support of the National
Cancer Institute, which has provided bryostatin as the natural drug
substance. We look forward to continuing our progress with
Bryostatin-1 and Neurotrope, as we work toward completing a merger
agreement with Metuchen Pharmaceuticals and delivering two unique
value-creating propositions to our stakeholders."
About Neurotrope, Inc.
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, and other activators of
PKC epsilon in AD, and preclinical studies for stroke, traumatic
brain injury, and rare diseases, including Fragile X
syndrome. Pre-clinical studies of Bryostatin in other
laboratories have included multiple sclerosis, autistic spectrum
disorders, and Niemann-Pick Type C disease. 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.
Neurotrope has entered into a definitive merger agreement
pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope
have agreed to merge in an all-stock transaction resulting in a
newly formed holding company focused on men's health conditions,
which will be named Petros Pharmaceuticals, Inc. ("Petros").
Upon closing of the transaction, Bryostatin-1 and substantially all
of Neurotrope's existing assets, operations and liabilities, except
for cash retained by Petros in accordance with the terms of the
merger agreement, will be spun-out into a new, separately traded
company named Neurotrope Bioscience, Inc.
Additional information about Neurotrope may be found on its
website: www.neurotrope.com.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between Petros,
Neurotrope and Metuchen, Petros intends to file relevant materials
with the SEC, including a registration statement that will contain
a proxy statement and prospectus. BEFORE MAKING ANY VOTING OR
INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ
THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR
SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT
NEUROTROPE MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTIONS. Stockholders may obtain, free of charge, copies of
the definitive proxy statement/prospectus and any other documents
filed by Petros with the SEC in connection with the proposed
transactions at the SEC's website (www.sec.gov), at
Neurotrope's website: www.neurotrope.com, or by
directing written request to: Neurotrope, Inc., 1185
Avenue of the Americas, 3rd Floor, New York, New
York 10036, Attention: Robert Weinstein.
Participants in the Solicitation
Petros, Neurotrope, Metuchen and their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Neurotrope in
connection with the proposed transaction. Information regarding the
special interests of these directors and executive officers in the
merger will be included in the proxy statement/prospectus referred
to above. Additional information regarding the directors and
executive officers of Neurotrope is also included in Neurotrope's
Annual Report on Form 10-K for the year ended December 31,
2019, filed with the SEC on March 13, 2020. This document is
available free of charge at the SEC web site (www.sec.gov), at
Neurotrope's website, or by directing a written request to
Neurotrope as described above.
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 Petros, Neurotrope, Metuchen, the combined company, the
proposed merger transaction, spin-off and other related matters,
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
complete the merger transaction with Metuchen or realize the
expected benefits from such 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
risk that the conditions to the closing of the proposed
transactions are not satisfied, including the failure to obtain
stockholder approval for the proposed transactions in a timely
manner or at all, uncertainties as to the timing of the
consummation of the proposed transactions and the ability of each
of Petros, Neurotrope and Metuchen to consummate the proposed
transactions, 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, 2019, Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K filed with the
SEC. Except as required by law, the Company does not undertake to
update these forward-looking statements.
Contacts
Corporate:
Robert
Weinstein
Chief Financial Officer
973.242.0005 ext. 101 | rweinstein@neurotrope.com
Investors and Media:
Lisa
Sher
Argot Partners
212.600.1902 | lisa@argotpartners.com
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SOURCE Neurotrope, Inc.
