Neurotrope Announces Positive Top-Line Results From Its Phase 2a Study of Bryostatin-1 in Alzheimer’s Disease
Study Meets Primary Endpoint of Safety and Tolerability
Newark, NJ, February 24, 2015 – Neurotrope, Inc. (OTCQB: NTRP) today announced positive top-line results from its randomized, double-blind, placebo-controlled, single dose Phase 2a clinical trial evaluating bryostatin-1 for the treatment of Alzheimer’s disease (AD). Bryostatin is a potent modulator of an enzyme called protein kinase C epsilon (PKCe). In animal models of Alzheimer’s disease activation of PKCe has been shown to play an important role in improving memory and learning.
This Phase 2a safety study in nine Alzheimer’s patients has met its primary endpoint demonstrating preliminary safety and tolerability of bryostatin. There were no serious adverse events. All adverse events were considered mild and resolved spontaneously. There were no clinically significant laboratory abnormalities. Thus, there were no safety signals identified and bryostatin was well tolerated.
The secondary objectives of the study were the preliminary evaluation of the efficacy of a single dose of bryostatin in the treatment of patients with AD, its pharmacokinetics and pharmacodynamics and to correlate the changes in PKCe with plasma levels of bryostatin and with improvement in cognitive function. The data regarding these secondary endpoints are still being reviewed.
Commenting on today’s news, Charles S. Ramat, President and Chief Executive Officer of Neurotrope, Inc., said, “Through our partnership with the Blanchette Rockefeller Neurosciences (BRNI), our licensor, and the drug provided by the National Cancer Institute (NCI), we were able to successfully complete this clinical trial and plan for the next one. Given that bryostatin has been used by the NCI in over 1,000 cancer patients, at much higher doses, with no significant safety signals, we were confident that this first trial in Alzheimer’s patients would follow that pattern and, indeed, the Phase 2a showed good safety and tolerability. While we recognize that this is a small trial population we are greatly encouraged to proceed with our next planned clinical trial.”
Warren W. Wasiewski, MD, Executive Vice President and Chief Medical Officer of Neurotrope, noted, “Given these encouraging results, we are now planning a Phase 2b, multi-site, double-blind, placebo controlled trial of approximately 150 patients in moderately severe to severe AD patients. We recently assembled a world-class Alzheimer’s Clinical Advisory Board, including some of the world’s top experts in the field. They are guiding us as we finalize our protocol submission to the U.S. Food and Drug Administration.”
About Neurotrope’s Approach to Alzheimer’s
Please visit www.neurotropebioscience.com for further information.
For additional information, please contact:
Chief Financial Officer