Neurotrope, Inc. (NASDAQ:NTRP) ("Neurotrope" or the "Company") today announced that its wholly-owned subsidiary, Neurotrope Bioscience, Inc. ("NBI"), has entered into a services agreement with Worldwide Clinical Trials ("WCT") to support site recruitment and activation for the Company's ongoing Phase 2 study of bryostatin-1 in the treatment of moderately severe Alzheimer's disease ("AD"). The Phase 2 clinical study is being conducted in collaboration with the National Institutes of Health ("NIH") under a $2.7 million grant to Neurotrope. Details of the agreement are included in a Current Report on Form 8-K filed by Neurotrope with the Securities and Exchange Commission (the "SEC") on July 29, 2020.
"This agreement with WCT is an important step forward as we begin enrolling patients in our Phase 2 trial of Bryostatin-1 for Alzheimer's disease later this year," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. "This is our first extended trial that will include twice the number of treatment doses than used previously. Understanding Bryostatin-1's potential to treat moderately severe patients – a population informed by benefit seen in our prior studies – is critical to potentially delivering new treatment options to this neglected area of AD research, where no effective treatments currently exist."
This Phase 2 clinical study 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. This 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. Neurotrope expects to dose the first patient in late third quarter or early fourth quarter of 2020.
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.