Neurotrope Announces First Patient Dosed in Long-Term Clinical Trial of Bryostatin in Alzheimer's Disease
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.
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.
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SOURCE Neurotrope, Inc.