Top-line efficacy data expected to be announced during the Third Quarter of 2019
NEW YORK, July 15, 2019 /PRNewswire/ -- Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that the Company has concluded data collection in its confirmatory Phase 2 double blind, placebo controlled clinical trial of Bryostatin-1 in the treatment of moderately severe to severe AD.
Data from the previous exploratory Phase 2 trial demonstrated clear safety and showed greater than baseline improvements in Severe Impairment Battery (SIB) scores that were sustained for patients in the 20µg Bryostatin-1 dose group not on memantine. The current confirmatory Phase 2, multi-center trial is designed to assess the safety and efficacy of Bryostatin-1 as a treatment for cognitive deficits in 108 patients with moderate to severe AD, defined as a Mini Mental State Exam 2 score of 4 - 15, who are not currently taking memantine. Patients were randomized 1:1 to be treated with either Bryostatin-1 20μg or placebo, receiving 7 doses over 12 weeks. Patients on memantine, an NMDA receptor antagonist, were excluded unless they had been discontinued from memantine treatment for a 30-day washout period prior to study enrollment. The primary efficacy endpoint is the change in the SIB score between the baseline and week 13. Secondary endpoints include repeated SIB changes from baseline SIB at weeks 5, 9, 13 and 15.
"Prior animal studies have demonstrated bryostatin's potential for restorative synaptogenesis, prevention of neuronal death, anti-inflammation, anti-amyloid, and anti-hyperphosphorylation of tau via the activation of PKC epsilon. This multi-modal activity could potentially distinguish Bryostatin-1 from previously tested drug candidates that predominantly targeted amyloid plaque or tau neurofibrillary tangles," stated Dr. Daniel L. Alkon, Neurotrope's President and Chief Scientific Officer. "The loss of synaptic networks, potentially addressed by bryostatin, has been found in certain studies to correlate with the severity of cognitive dysfunction and disease progression."
"We believe that bryostatin could possibly have transformative potential as a treatment for moderate to severe AD," said Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer. "We look forward to reporting top-line data from this study during the third quarter of 2019, which could be a critical point of validation for our bryostatin platform."
Neurotrope is at the forefront of developing a new approach to combating AD and other neurodegenerative diseases. The Company's world-class science offers the potential to realize a paradigm shift to overcome one of today's most challenging clinical problems — finding a way to slow or even prevent the progression of AD.
In addition to the Company's Phase 2 trial of Bryostatin-1 in advanced AD, Neurotrope has also conducted preclinical studies of Bryostatin-1 as a potential treatment 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. 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.
Please visit www.neurotrope.com for further information.
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 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 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 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, 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 Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2018, and on Form 10-Q for the quarter ended March 31, 2019. The Company does not undertake to update these forward-looking statements.
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