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news.Neurotrope's subsidiary Neurotrope BioScience has submitted to the Food and Drug Administration (FDA) an amended protocol for its Phase 2 clinical trial of lead candidate bryostatin-1 for the treatment of advanced Alzheimer’s disease.
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As planned in the original protocol, the primary efficacy outcome will occur at Week 13, and does not change with this amendment. The primary efficacy endpoint is based on the Severe Impairment Battery scale, a well-validated assessment used extensively in severe Alzheimer’s disease drug trials.
Secondary efficacy endpoints include Activities of Daily Living, Neuropsychiatric Inventory and Mini-Mental State Exam. As a result of this amendment, the Company expects to report top line data late in the first quarter or early in the second quarter of 2017.
The original protocol of the clinical trial was designed to evaluate the safety and efficacy of two doses of bryostatin-1 (20µg or 40µg) versus placebo, followed by a total of seven doses administered over 12 weeks, with the primary efficacy evaluation at week 13.
For exploratory purposes, a second study period of 12 weeks immediately followed the 13 week primary evaluation, with patients in the bryostatin-1 arms re-randomized to either receive the other dose of bryostatin-1 or stay on the same dose. Patients in the placebo arm were re-randomized to receive either bryostatin-1 (10µg) or placebo.
This protocol amendment eliminates the second study period, enabling the final analysis to take place immediately following the primary efficacy evaluation. Subjects who have already entered the second study period will have treatment discontinued. All subjects will have a final evaluation 30 days after the last dose of study drug.
“Eliminating the second randomization enables an earlier completion of the study, accelerates planning of future studies and does result in a significant cost and time savings,” said Dr. Daniel Alkon, Chief Scientific Officer of Neurotrope, Inc.
“The study remains blinded without any interim data analysis performed. This decision was made solely to accelerate the evaluation and clinical development of bryostatin.” Dr. Alkon continued, “We are excited to be able to anticipate the final data from the trial earlier than previously expected.”