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.
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.
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.
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