Neurotrope Bioscience Concludes Patient Dosing and Monitoring in its 148 Patient Phase 2 Clinical Trial of Moderate to Severe Alzheimer’s Dementia
Top-line efficacy data is expected to be announced in April 2017
NEW YORK, February 28, 2017 /PRNewswire/ — Neurotrope, Inc. (OTCQB: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease, announced the conclusion of dosing and patient monitoring in its Phase 2 double blind, placebo controlled clinical trial of bryostatin-1 in the treatment of moderate to severe Alzheimer’s dementia. Patients underwent a 12 week treatment with bryostatin-1, followed by a 30-day post-treatment evaluation. The study is designed to assess the therapeutic efficacy of bryostatin-1, a PKC epsilon activator. Prior animal studies have demonstrated bryostatin’s efficacy for restorative synaptogenesis, prevention of neuronal death, and anti-amyloid, anti-tau metabolism via the activation of PKC epsilon.
“We are very pleased with the execution of the study. It took only about 13 months from initiation of randomization of the study to completion the last patient visit,” Dr. Susanne Wilke, Chief Executive Officer of Neurotrope stated.
“The multi-modal efficacy of bryostatin-1 was extensively studied in both animal models and Expanded Access patients with advanced Alzheimer’s dementia. We believe that these studies demonstrated bryostatin’s potential to actually improve cognitive functions, not simply slow the rate of cognitive decline,” stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope.
“A reversal of Alzheimer’s progression would represent a major step forward in the treatment of Alzheimer’s dementia patients after years of failed previous trials by other companies and institutions that predominantly targeted amyloid plaque or tau neurofibrillary tangles. Those trials, thus far, have not achieved a significantly reduced rate of decline or improved cognition in any group of patients diagnosed with Alzheimer’s dementia, mild, moderate, or severe,” stated Dr. Wilke.
“Although the pathologic hallmarks of Alzheimer’s disease, extracellular plaques and intracellular tangles at autopsy, are essential to identify those demented patients who had Alzheimer’s dementia, plaques and tangles are not closely related to functional decline. In contrast, the loss of synaptic networks has been found, with numerous autopsy studies, to correlate with the severity of cognitive dysfunction and disease progression,” stated Dr. Alkon. “We, at Neurotrope, believe that the regenerative effects of bryostatin’s treatment on the synapses, as well as bryostatin’s prevention of amyloid and plaque deposition, may not just reduce, but potentially reverse the symptoms, by addressing for the first time many of the major early causes of this devastating disease.”
Neurotrope is at the forefront of developing a novel therapy to treat and potentially reverse moderate to severe Alzheimer’s disease and other neurodegenerative diseases. The Company’s world-class science is a paradigm shifting approach that treats some of the underlying causes of Alzheimer’s disease.
The scientific basis of our treatment is activation of Protein Kinase C isozymes ε and α by bryostatin-1, a natural product, which in mouse Alzheimer’s disease models was demonstrated to result in repair of damaged synapses as well as synaptogenesis, the induction of new neuronal networks, reduction of toxic beta-amyloid generation, prevention of neuronal death, and enhancement of memory and learning, thus having the potential to improve cognition and behavior in Alzheimer’s dementia.
Neurotrope is conducting a Phase 2 trial of bryostatin-1 in the treatment of moderate to severe Alzheimer’s dementia, as well as preclinical studies of bryostatin-1 as a treatment for Fragile X Syndrome, Niemann-Pick Type C disease and Rett Sydrome, three rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for bryostatin-1 as a treatment for Fragile X Syndrome. Bryostatin-1 has undergone testing in over 1,500 people establishing a large safety database.
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 the proposed study and timing of initiation, and continued development of use of bryostatin-1 for Alzheimer’s disease and other cognitive diseases, and the Company’s ability to list its common shares on a major stock exchange. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. 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. Factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, 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 the Company’s business, the Company’s inability to meet listing requirements for major stock exchanges, 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 the Company’s 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 Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 and its prospectus dated February 14, 2017. The Company does not undertake to update these forward-looking statements.
Please visit www.neurotropebioscience.com for further information.
For additional information, please contact:
Neurotrope Bioscience, Inc.
Jeffrey Benison, Director of Corporate Communications
212.334.8709 or 516.286.6099