Neurotrope Doses First Patients in Phase 2b Study of Bryostatin for Treatment of Severe Alzheimer’s Disease
Interim Data Anticipated Q1 2017
Newark, NJ, February 11, 2016 – Neurotrope, Inc. (NTRP) today announced that the first patients have been dosed in the Company’s Phase 2b clinical trial of its lead candidate, Bryostatin-1, for the treatment of advanced Alzheimer’s disease.
“We believe that Bryostatin represents a new and disruptive technology in what has been an unsuccessful war against Alzheimer’s disease. This trial seeks to statistically verify preliminary results seen in compassionate use patients and patients treated in our completed Phase 2a study,” said Charles S. Ramat, President and CEO of Neurotrope. “We are excited at being on the cusp of providing a meaningful treatment to this suffering, severely impaired population and their caregivers.”
The Bryostatin-1 Phase 2b trial is an ongoing randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of the drug in the treatment of patients suffering from moderately severe to severe Alzheimer’s disease. The study plans to enroll 150 patients at a total of 30 participating U.S. sites. The Company recently hosted an Investigators Meeting to provide the in-depth training necessary for the trial to more than 150 healthcare clinical professionals.
The clinical trial will evaluate two different doses of Bryostatin (20 or 40µg) versus placebo, with a total of seven doses administered over 12 weeks. A second randomization will take place after the first 12 weeks of treatment, with patients in the Bryostatin arms to receive either a different dose of Bryostatin or the same dose. Patients in the placebo arm will be randomized to receive either Bryostatin (10µg) or placebo. The primary efficacy endpoint is based on the Severe Impairment Battery (SIB) Scale, a benchmark assessment used extensively in severe Alzheimer’s disease drug trials. Secondary efficacy endpoints include Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI) and Mini-Mental State Exam (MMSE).
The Company expects to report three month interim data during the first quarter of 2017 with the complete six month data set expected during the first half of 2017.
Neurotrope BioScience, Inc., a wholly owned subsidiary of Neurotrope, Inc., is at the forefront of biotechnology companies having a focus on developing a novel therapy for the treatment of moderately severe to severe Alzheimer’s disease. The scientific basis of our treatment is activation of Protein Kinase C isozymes ε and α by bryostatin, a natural product, which can result in repair of damaged synapses as well as synaptogenesis, reduction of toxic amyloid generation, and enhancement of memory and learning, thus having the potential to improve cognition and behavior in Alzheimer’s disease.
Neurotrope is also conducting preclinical studies of bryostatin as a treatment for Fragile X Syndrome and Niemann-Pick Type C disease, two rare genetic diseases for which only symptomatic treatments are currently available. The Food and Drug Administration has granted Orphan Drug Designation to Neurotrope for bryostatin as a treatment for Fragile X Syndrome.
NTRP has exclusively licensed technology from the Blanchette Rockefeller Neurosciences Institute for Alzheimer’s disease and Fragile X Syndrome, has a world-wide, exclusive license with the Icahn School of Medicine at Mt. Sinai for Niemann-Pick Type C disease and is partnered with Stanford University to synthesize and find the next generation bryostatin – called bryologs.
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 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2015. The Company does not undertake to update these forward-looking statements.
Please visit www.neurotropebioscience.com for further information.
For additional information, please contact:
The Ruth Group for Neurotrope Bioscience:
Lee Roth (Investors) / Kirsten Thomas (Media)
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