Neurotrope Launches New Long-Term Clinical Trial of Bryostatin with the National Institutes of Health for the Treatment of Patients with Alzheimer's Disease
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.
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.
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Company Codes: NASDAQ-SMALL:NTRP