Neurotrope Announces First Patient Dosed in Bryostatin Trial for Alzheimer's Disease

Neurotrope has announced the dosing of the first patient in its ongoing, long-term Phase 2 study of Bryostatin-1 for the treatment of Alzheimer's disease (AD). The study will be conducted in collaboration with the National Institutes of Health ("NIH") under a $2.7 million grant to Neurotrope.

The new Phase 2 clinical study, which is expected to enroll approximately 100 patients, will evaluate Bryostatin-1 in the absence of Namenda® (memantine) for a six-month period, which will include two 11-week dosing cycles.  The study will focus on AD patients with pre-specified moderately severe (Moderate Stratum; MMSE-2 baseline score 14-10) and moderate (MMSE-2 baseline score 18–15) disease, including a patient population that demonstrated the most evidence of benefit in a prior study, and will focus on assessing sustained cognitive benefit as measured by the Severe Impairment Battery ("SIB") score, a widely accepted measure of cognitive function in advanced dementia patients.   Analysis of the data will be conducted in consultation with Dr. Richard Thompson, Senior Scientist from the Bloomberg School of Public Health at Johns Hopkins University.

"After reviewing data from previous trials of Bryostatin-1 with both key opinion leaders and the NIH, we determined that a study to evaluate its long-term therapeutic effects in the absence of Namenda® in patients with AD was a priority," said Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "We have made rapid progress in commencing this study, and are very pleased to announce today that the first patient has been dosed after significant progress in patient enrollment. Among its potential effects, bryostatin has been shown, pre-clinically, to reverse damage to the synaptic connections between neurons that occurs in AD patients.  AD remains among the most significant public health challenges of our modern era and, with support from the NIH, we hope to deliver progress toward advancing a new and innovative, disease modifying treatment."

This Phase 2 study is supported by Phase 2 clinical data from a completed pilot trial (NTRP101-202) which evaluated Bryostatin-1 in the absence of Namenda® in a short-term, 11-week treatment protocol.  In this prior study, Bryostatin-1 (20 mcg) was well tolerated and showed early signals of cognitive benefit, including improvement of 5.0 points in SIB score compared to baseline in the Moderate Stratum cohort in the non-Namenda® group.  This SIB score improvement was sustained throughout the treatment period and persisted for four weeks following completion of treatment.  A second pilot trial (NTRP101-203) using the same treatment protocol (Bryostatin-1 in the absence of Namenda® for 11 weeks) showed a similar SIB improvement compared to baseline for the Moderate Stratum cohort.

"We believe that Neurotrope's proprietary platform holds potential for developing treatments for Alzheimer's and other major neurological diseases," said Josh Silverman, Chairman of the Board of Neurotrope. "Dosing the first patient in our Phase 2 study of Bryostatin-1 in AD is an important milestone for Neurotrope, and we remain grateful for the ongoing support and validation from the National Institute on Aging at the NIH. We also appreciate the ongoing support of the National Cancer Institute, which has provided bryostatin as the natural drug substance.  We look forward to continuing our progress with Bryostatin-1 and Neurotrope, as we work toward completing a merger agreement with Metuchen Pharmaceuticals and delivering two unique value-creating propositions to our stakeholders."