Neurotrope, NIH Launch Clinical Trial of Bryostatin for Alzheimer's Disease

Neurotrope announced the launch of a new long-term study of Bryostatin-1 for the treatment of patients with Alzheimer's disease (AD). The Phase 2 clinical study will be conducted in collaboration with the National Institutes of Health (NIH) under a $2.7 million grant to Neurotrope. After reviewing the data from the previous trial with Key Opinion Leaders and the NIH, we designed a study to evaluate the long-term therapeutic effect of Bryostatin-1 in the absence of Namenda® (memantine) in patients with AD. The Company has engaged Worldwide Clinical Trials to initiate site recruitment and activation.

As recently announced, Neurotrope has entered into a definitive merger agreement pursuant to which Metuchen Pharmaceuticals and Neurotrope have agreed to merge in an all-stock transaction resulting in a newly formed holding company focused on men's health conditions, which will be named Petros Pharmaceuticals. Upon closing of the transaction, Bryostatin-1 and substantially all of Neurotrope's existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the merger agreement, will be spun-out into a new, separately traded company which will retain the name Neurotrope Bioscience, Inc. (NBI).

"The initiation of a new Bryostatin-1 study in AD, and our efforts in advancing a merger with Metuchen, underscore what we believe is a unique opportunity for our investors to participate in two distinct, publicly-listed companies with potentially meaningful value propositions: Petros Pharmaceuticals, Inc. and the spin-out company NBI," said Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer.

"We are very excited to advance Bryostatin-1 to its next phase of development," said Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "Central to this new development effort is to study Bryostatin-1's efficacy over a longer course of treatment and in patients whom we believe show the most potential for clinical benefit. Given the high unmet need for new therapies to treat AD, recognized by the NIH and highlighted by their financial and scientific support, we plan to move this program forward as rapidly as possible, with the goal of demonstrating Bryostatin-1's potential benefit in this setting. Many other AD studies have been longer in duration than the studies we previously conducted."

The new Phase 2 clinical study, which is expected to enroll approximately 100 patients, will evaluate Bryostatin-1 in the absence of Namenda for a 6-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. This study will be conducted in collaboration with the NIH who has awarded to Neurotrope $2.7 million in funding to further investigate the therapeutic effect of Bryostatin-1 in this patient population. 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. Neurotrope expects to dose the first patient in late third quarter or early fourth quarter this year.

This new 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 a 5.0 improvement 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 4 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.