NEW YORK, Oct. 24, 2018 /PRNewswire/ -- Neurotrope Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease, today announced the presentation of updated data from the Phase 2, multidose, exploratory trial evaluating Bryostatin-1 as a treatment of cognitive deficits in moderate to severe Alzheimer's disease ("AD"). The data were presented in a poster, entitled "Evidence of Sustained Low Dose Bryostatin Efficacy for Treatment of Alzheimer's Disease: Consistency of Multiple Evaluation Analyses" at the 11th Edition of Clinical Trials on Alzheimer's Disease ("CTAD") being held in Barcelona, Spain from October 24th - 27th, 2018.
"We are encouraged by the findings of this exploratory trial as we believe they are suggestive of the primary mechanisms of action of bryostatin, synaptogenesis and anti-apoptosis, or the generation of new, mature synaptic connections and the prevention of neuronal death," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "These results show a potential reversal of disease progression occurring in patients with moderate to severe AD treated with Bryostatin-1. Notably, this improvement persisted even 30 days after completion of all drug administration."
This study was designed to assess the safety and efficacy of Bryostatin-1 as a treatment of cognitive deficits in patients with moderate to severe AD (n=147). Patients enrolled in the study were allowed to continue on background therapy, including cholinergic and/or antiglutamatergic treatment. The primary efficacy analysis was change in Severe Impairment Battery (SIB) scores. For patients in the 20 µg Bryostatin-1 dose group (n=49, with 38 completers), the dose group being explored in an ongoing confirmatory Phase 2 study, SIB scores were consistently greater than baseline, indicating improvement in cognitive function. The magnitude of improvement was greater in a pre-specified exploratory analysis of patients not on memantine therapy (n=16). Memantine is an antiglutamatergic treatment whose mechanism of action may interfere with that of bryostatin-1. Analyses of patients in this group showed evidence of sustained SIB improvement over baseline compared to placebo patients not on memantine (> 6.30 points, 8.4 points when compared to all placebo). Individual patient trends over time revealed that 15 out of 16 patients (94%) in the 20μg Bryostatin-1, non-memantine group showed improvement in SIB by the end of the trial. No increase in SIB measures over time for the placebo patients or for patients on baseline memantine therapy was found.
A model for repeated measures (MMRM) was used in the trend analysis to provide consistency with the analysis of the whole patient sample. Based on the statistical trend analysis, the 20 μg Bryostatin-1 in the absence of memantine group shows a significant positive SIB trend (e.g. SIB improving over time). The treatment-by-time interaction, indicating a difference in treatment effect by arm, was highly significant (p < 0.001). These data indicate that benefit for the patients in the memantine-free group increase with dosing over time, including throughout the 15 week protocol.
Neurotrope is evaluating the 20 µg dose of Bryostatin-1 in patients not on memantine in a confirmatory Phase 2 trial, initiated in July, 2018, and evaluating 100 moderate-to-severe AD patients. Data from this study are expected during the second half of 2019.
The poster presentation information and poster presentation link are listed below.
Title: Evidence of Sustained Low Dose Bryostatin Efficacy for Treatment of
Alzheimer's Disease: Consistency of Multiple Evaluation Analyses
Abstract #: LBP14
Presentation Theme: Clinical trials: Results
Date/Time: Wednesday, October 24th, 2018: 1:00 – 4:00 PM
Location: Palau de Catalunya Conference Center
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 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. 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 June 30, 2018. The Company does not undertake to update these forward-looking statements.
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