First patients dosed in Neurotrope's Bryostatin-1 Phase 2b trial for treatment of advanced Alzheimer’s disease

Feb 16 2016

Interim Data Anticipated Q1 2017

Neurotrope, Inc. (NTRP) today announced that the first patients have been dosed in the Company’s Phase 2b clinical trial of its lead candidate, Bryostatin-1, for the treatment of advanced Alzheimer’s disease.

“We believe that Bryostatin represents a new and disruptive technology in what has been an unsuccessful war against Alzheimer’s disease. This trial seeks to statistically verify preliminary results seen in compassionate use patients and patients treated in our completed Phase 2a study,” said Charles S. Ramat, President and CEO of Neurotrope. “We are excited at being on the cusp of providing a meaningful treatment to this suffering, severely impaired population and their caregivers.”

The Bryostatin-1 Phase 2b trial is an ongoing randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of the drug in the treatment of patients suffering from moderately severe to severe Alzheimer’s disease. The study plans to enroll 150 patients at a total of 30 participating U.S. sites. The Company recently hosted an Investigators Meeting to provide the in-depth training necessary for the trial to more than 150 healthcare clinical professionals.

The clinical trial will evaluate two different doses of Bryostatin (20 or 40µg) versus placebo, with a total of seven doses administered over 12 weeks. A second randomization will take place after the first 12 weeks of treatment, with patients in the Bryostatin arms to receive either a different dose of Bryostatin or the same dose. Patients in the placebo arm will be randomized to receive either Bryostatin (10µg) or placebo. The primary efficacy endpoint is based on the Severe Impairment Battery (SIB) Scale, a benchmark assessment used extensively in severe Alzheimer’s disease drug trials. Secondary efficacy endpoints include Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI) and Mini-Mental State Exam (MMSE).

The Company expects to report three month interim data during the first quarter of 2017 with the complete six month data set expected during the first half of 2017.