Neurotrope Concludes Data Collection in Alzheimer's Disease Clinical Trial

Neurotrope announced that the Company has concluded data collection in its confirmatory Phase 2 double blind, placebo controlled clinical trial of Bryostatin-1 in the treatment of moderately severe to severe AD.

Data from the previous exploratory Phase 2 trial demonstrated clear safety and showed greater than baseline improvements in Severe Impairment Battery (SIB) scores that were sustained for patients in the 20µg Bryostatin-1 dose group not on memantine. The current confirmatory Phase 2, multi-center trial is designed to assess the safety and efficacy of Bryostatin-1 as a treatment for cognitive deficits in 108 patients with moderate to severe AD, defined as a Mini Mental State Exam 2 score of 4 - 15, who are not currently taking memantine. Patients were randomized 1:1 to be treated with either Bryostatin-1 20μg or placebo, receiving 7 doses over 12 weeks. Patients on memantine, an NMDA receptor antagonist, were excluded unless they had been discontinued from memantine treatment for a 30-day washout period prior to study enrollment.  The primary efficacy endpoint is the change in the SIB score between the baseline and week 13. Secondary endpoints include repeated SIB changes from baseline SIB at weeks 5, 9, 13 and 15.

"Prior animal studies have demonstrated bryostatin's potential for restorative synaptogenesis, prevention of neuronal death, anti-inflammation, anti-amyloid, and anti-hyperphosphorylation of tau via the activation of PKC epsilon. This multi-modal activity could potentially distinguish Bryostatin-1 from previously tested drug candidates that predominantly targeted amyloid plaque or tau neurofibrillary tangles," stated Dr. Daniel L. Alkon, Neurotrope's President and Chief Scientific Officer. "The loss of synaptic networks, potentially addressed by bryostatin, has been found in certain studies to correlate with the severity of cognitive dysfunction and disease progression."

"We believe that bryostatin could possibly have transformative potential as a treatment for moderate to severe AD," said Dr. Charles S. Ryan, Neurotrope's Chief Executive Officer.  "We look forward to reporting top-line data from this study during the third quarter of 2019, which could be a critical point of validation for our bryostatin platform."

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