NEW YORK, July 25, 2018 /PRNewswire/ -- Neurotrope, Inc. (NASDAQ: NTRP) today presented additional clinical results from its recently completed Phase 2 trial demonstrating that moderate-to-severe Alzheimer's disease (AD) patients treated with 20 µg Bryostatin-1 showed evidence of sustained improvement in cognition compared with placebo in patients not on concomitant memantine treatment, with a safety profile similar to placebo. The data and comprehensive statistical analysis are being presented in the Developing Topics Poster Presentation, "Significant Cognitive Improvement with Bryostatin for Advanced Alzheimer's Patients in the Absence of Memantine" at the Alzheimer's Association International Conference 2018 in Chicago.
In preclinical studies Bryostatin-1 lowers beta amyloid levels by the activation of natural enzymatic pathways in the brain such as IDE, ECE and neprilysin. Bryostatin has also shown synaptogenesis and prevention of neuronal death in extensive pre-clinical studies by activating synaptic growth factors such as BDNF, IGF and NGF. Further data analysis of the recent Phase 2 trial results showed that advanced AD patients show improvement (> 6.0 points vs. placebo and baseline) in the Severe Impairment Battery (SIB) even 30 days after all drug dosing has been completed in patients not on memantine.
"Patients not on memantine treatment exhibited significant cognitive improvement, at all time points tested during the trial, as evidenced by the SIB scores, with an average of 6.1 point improvement (p=0.012) over baseline and placebo," stated Dr. Richard Thompson, Senior Statistician, Bloomberg School of Public Health, Johns Hopkins University. Dr. Thompson continued, "Various sensitive, comparative analyses were also conducted and resulted in consistent conclusions, including sustainability of the treatment effect over time, even 30 days after all dosing was completed."
In Neurotrope's previous Phase 2 trial of Bryostatin-1 for moderate-to-severe AD patients, Severe Impairment Battery (SIB) scores were consistently greater than baseline, indicating improvement for patients treated with a specific dose regimen, (20 µg protocol). The magnitude of this SIB increase above baseline was much greater when a pre-specified exploratory analysis separated out patients who were not on standard of care memantine therapy. Patients not on memantine treatment exhibited an improvement of 6.1 points over baseline and placebo, in their SIB scores. This was confirmed using three different comprehensive statistical analyses detailed in the poster being presented. Patients dosed in the 20 µg group in combination with memantine background therapy, and the patients on placebo with donepezil background therapy, did not show an increase above the baseline score on the SIB scale.
"Because of the impressive improvement in the patients treated with the 20 µg dose of bryostatin who were not on memantine, Neurotrope has made the conservative decision to launch a confirmatory Phase 2 trial testing 100 moderate-to-severe AD patients with the 20 µg dose of Bryostatin-1 in a 1:1 ratio versus placebo. We are delighted to have initiated enrollment of the study earlier this month," said Dr. Charles Ryan, Neurotrope Chief Executive Officer.
Preclinical findings by other labs confirm that memantine would likely block bryostatin's observed improvement in cognition, due to their use of a shared cell signaling pathway. Both memantine and bryostatin engage the same receptor, the NMDA receptor. Memantine directly blocks the NMDA receptor. In the absence of memantine, bryostatin activates PKC, causing engagement of the NMDA receptor. These clinical study results validate Neurotrope's proposed mechanism of action for bryostatin and its expected effects at a neuronal level, further bolstering the Company's clinical program and informing the development of a pivotal trial protocol for Bryostatin-1 in moderate-to-severe AD patients.
The poster presentation information and a link to the poster is below.
Significant Cognitive Improvement with Bryostatin for Advanced Alzheimer's
Developing Topics Session:
Wednesday, July 25, 2018: 9:30 AM-4:15 PM CDT
F1 - McCormick Place
Link to the poster
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 as a potential treatment for Stroke, Traumatic Brain Injury, and Fragile X Syndrome, Niemann-Pick Type C disease and Rett Syndrome—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 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 in AD.
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 Alzheimer's 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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company's views of the Phase 2 data. 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 SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and on Form 10-Q for the quarter ended March 31, 2018. The Company does not undertake to update these forward-looking statements.
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Jeffrey Benison, Director of Corporate Communications
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