NEW YORK, July 30, 2020 /PRNewswire/ -- Neurotrope,
Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company") today announced
that its wholly-owned subsidiary, Neurotrope Bioscience, Inc.
("NBI"), has entered into a services agreement with Worldwide
Clinical Trials ("WCT") to support site recruitment and activation
for the Company's ongoing Phase 2 study of bryostatin-1 in the
treatment of moderately severe Alzheimer's disease ("AD").
The Phase 2 clinical study is being conducted in collaboration with
the National Institutes of Health ("NIH") under a $2.7 million grant to Neurotrope. Details of the
agreement are included in a Current Report on Form 8-K filed by
Neurotrope with the Securities and Exchange Commission (the "SEC")
on July 29, 2020.
"This agreement with WCT is an important step forward as we
begin enrolling patients in our Phase 2 trial of Bryostatin-1 for
Alzheimer's disease later this year," stated Dr. Daniel Alkon, Neurotrope's President and Chief
Scientific Officer. "This is our first extended trial that will
include twice the number of treatment doses than used
previously. Understanding Bryostatin-1's potential to
treat moderately severe patients – a population informed by benefit
seen in our prior studies – is critical to potentially delivering
new treatment options to this neglected area of AD research, where
no effective treatments currently exist."
This Phase 2 clinical study is expected to enroll approximately
100 patients, will evaluate Bryostatin-1 in the absence of Namenda
for a 6-month period, which will include two 11-week dosing
cycles. This 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. Neurotrope expects
to dose the first patient in late third quarter or early fourth
quarter of 2020.
This new 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 a 5.0 improvement 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 4 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.
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 AD, 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 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.
Neurotrope has entered into a definitive merger agreement under
which Metuchen Pharmaceuticals, L.L.C. ("Metuchen") and Neurotrope
will merge in an all-stock transaction resulting in a newly formed
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
operating 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,
which will be 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 About the Business
Combination and Where to Find It
In connection with the proposed transaction among Petros,
Neurotrope and Metuchen, Petros has filed a Registration Statement
on Form S-4, which includes a preliminary proxy statement of
Neurotrope. Petros intends to file additional relevant materials
with the SEC. NEUROTROPE URGES INVESTORS AND STOCKHOLDERS
TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT PETROS, NEUROTROPE, METUCHEN, THE PROPOSED TRANSACTIONS AND
RELATED MATTERS. Investors and shareholders will be able
to obtain free copies of the proxy statement, prospectus and other
documents filed by Petros and Neurotrope with the SEC (when they
become available) through the website maintained by the SEC at
www.sec.gov. In addition, investors and shareholders will be
able to obtain free copies of the proxy statement, prospectus and
other documents filed by Petros and Neurotrope with the SEC by
contacting Investor Relations by mail at Neurotrope, Inc.,
Attn: Investor Relations, 1185 Avenue of the Americas,
3rd Floor, New York, New
York 10036. Investors and stockholders are urged to
read the proxy statement, prospectus and the other relevant
materials when they become available before making any voting or
investment decision with respect to the proposed transaction.
Participants in the Solicitation
Petros, Neurotrope and Metuchen, and each of their respective
directors and executive officers and certain of their other members
of management and employees, may be deemed to be participants in
the solicitation of proxies in connection with the proposed
transaction. Information about Neurotrope's directors and executive
officers is 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. Additional information
regarding these persons and their interests in the transaction is
included in the Registration Statement on Form S-4 filed by Petros.
These documents can be obtained free of charge from the sources
indicated above.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. 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 the Company 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, including, without limitation: the risk that
the conditions to the closing of the transactions are not
satisfied, including the failure to obtain stockholder approval for
the transactions in a timely manner or at all; uncertainties as to
the timing of the consummation of the mergers and the spin-off of
Neurotrope's wholly-owned subsidiary, Neurotrope Bioscience, Inc.,
and the ability of each of Petros, Neurotrope and Metuchen to
consummate the transactions; risks related to Petros' initial
listing on The Nasdaq Capital Market at the closing of the proposed
transaction; risks related to Neurotrope's ability
to correctly estimate its operating expenses and its expenses
associated with the transaction; the ability of Neurotrope or
Metuchen to protect their respective intellectual property rights;
competitive responses to the transaction; unexpected costs, charges
or expenses resulting from the transaction; potential adverse
reactions or changes to business relationships resulting from the
announcement or completion of the transaction; and legislative,
regulatory, political and economic developments.. Additional
factors that may influence or cause actual results to differ
materially from expected or desired results may include, without
limitation, 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 SEC,
including the Company's Quarterly Report on Form 10-Q for the three
months ended March 31, 2020 and its
Annual Report on Form 10-K for the year ended December 31, 2019. 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.