- Company Expects to Report Top-Line Data during the Second Half of 2019 -
NEW YORK, March 13, 2019 /PRNewswire/ -- Neurotrope Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that it has initiated dosing in the final patient in the Company's randomized, double-blind, placebo-controlled, confirmatory Phase 2 clinical trial of Bryostatin-1 in moderate to severe AD patients not on memantine. A total of 108 patients were enrolled into the study.
"Completion of enrollment in our confirmatory Phase 2 trial is an important step toward understanding the transformative potential of Bryostatin in moderate to severe Alzheimer's disease, a neglected area of AD research with no effective treatment options," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "Bryostatin uses a novel, multi-modal mechanism of action which has demonstrated the ability to generate new, mature synaptic connections and prevent neuronal death in AD models. The promising data from our previous exploratory Phase 2 trial showed greater than baseline improvements in Severe Impairment Battery (SIB) scores for patients in the 20 µg Bryostatin-1 dose group, suggesting the potential to translate Bryostatin's neurorestorative properties in the clinic."
The current confirmatory Phase 2 multicenter trial is designed to assess the safety and efficacy of Bryostatin-1 as a treatment for cognitive deficits in 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.
"We believe that Bryostatin may have transformative potential as a treatment for moderate to severe AD," stated Dr. Charles Ryan, Chief Executive Officer of Neurotrope. "This confirmatory Phase 2 study could be a critical point of validation for our Bryostatin platform. We look forward to reporting top-line data from this study in the second half of 2019, and to making continued progress in exploring Bryostatin's potential in other disease indications."
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, dementia 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. The Company does not undertake to update these forward-looking statements.
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