NEW YORK, May 28, 2020 /PRNewswire/ -- Neurotrope,
Inc. (Nasdaq: NTRP) today announced the launch of a new long-term
study of Bryostatin-1 for the treatment of patients with
Alzheimer's disease (AD). The Phase 2 clinical study will be
conducted in collaboration with the National Institutes of Health
(NIH) under a $2.7 million grant to
Neurotrope. After reviewing the data from the previous trial
with Key Opinion Leaders and the NIH, we designed a study to
evaluate the long-term therapeutic effect of Bryostatin-1 in the
absence of Namenda® (memantine) in patients with
AD. The Company has engaged Worldwide Clinical Trials to
initiate site recruitment and
activation.
As recently announced, 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 which will retain the name Neurotrope
Bioscience, Inc. ("NBI").
"The initiation of a new Bryostatin-1 study in AD, and our
efforts in advancing a merger with Metuchen, underscore what we
believe is a unique opportunity for our investors to participate in
two distinct, publicly-listed companies with potentially meaningful
value propositions: Petros Pharmaceuticals, Inc. and the spin-out
company NBI," stated Dr. Charles S.
Ryan, Neurotrope's Chief Executive Officer.
"We are very excited to advance Bryostatin-1 to its next phase
of development," stated Dr. Daniel
Alkon, President and Chief Scientific Officer of
Neurotrope. "Central to this new development effort is to
study Bryostatin-1's efficacy over a longer course of treatment and
in patients whom we believe show the most potential for clinical
benefit. Given the high unmet need for new therapies to treat
AD, recognized by the NIH and highlighted by their financial and
scientific support, we plan to move this program forward as rapidly
as possible, with the goal of demonstrating Bryostatin-1's
potential benefit in this setting. Many other AD studies have been
longer in duration than the studies we previously
conducted."
Dr. Alkon concluded: "We believe that the valuable insights
gained from our previous studies have provided crucial guidance for
our next trial to increase the possibility of observing clinically
meaningful benefits for Alzheimer's patients with concrete evidence
of dementia, benefits that may also possibly translate to MS,
stroke and Fragile X, as preclinical studies suggest."
Dr. Marwan Sabbagh, Director,
Cleveland Clinic Lou Ruvo Center for Brain Health, advisor on the
design of this 204 trial and a paid member of the Company's
Scientific Advisory Board, concurred: "Conducting a clinical trial
longer in duration may help address some of the placebo effect seen
in earlier studies."
Dr. George Perry, Professor of
Biology and Chemistry, Semmes Distinguished University Chair in
Neurobiology, University of Texas at San
Antonio and Editor-in-Chief of the Journal of Alzheimer's
Disease, added: "We are hopeful that this trial can substantiate
certain compelling data with Bryostatin from previous trials, which
suggests patients could potentially see improvement in their
disease which, I believe, would be transformative as an AD
treatment. When I see this in the context of currently available
drugs, I believe Bryostatin could chart a new path in how we treat
Alzheimer's disease."
New Phase 2 Study to Evaluate Long-Term Therapeutic Effect of
Bryostatin-1 in AD
The new Phase 2 clinical study, which 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. 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. This study will be
conducted in collaboration with the NIH who has awarded to
Neurotrope $2.7 million in funding to
further investigate the therapeutic effect of Bryostatin-1 in this
patient population. 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 this year.
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.
Conference Call and Webcast Information
The Neurotrope management team will host a conference call and
webcast today, Thursday, May 28,
2020, at 11:00 AM ET.
The call can be accessed by dialing (833) 651-0992 (U.S. and
Canada) or (918) 922-6081
(international), five minutes prior to the start of the call and
providing the passcode1870579.
The live, listen-only webcast of the conference call can be
accessed by visiting the "Events & Presentations" page in the
"Investors & Media" section of the Company's website at
www.neurotrope.com or by using the following link:
https://edge.media-server.com/mmc/p/mrk8cbq5. A replay of the
webcast will be archived on the Company's website for 30 days
following the call.
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, 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 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 NBI'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
Definitive Proxy Statement on Schedule 14A relating to the 2019
Annual Meeting of Stockholders, which was filed with the SEC on
June 5, 2019. 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 and the
Company's Current Report on Form 8-K filed on May 18, 2020. 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.