Neurotrope revealed first patients have been dosed in its phase 2b clinical trial of lead candidate Bryostatin-1 for advanced Alzheimer’s disease.
() revealed first patients have been dosed in its phase 2b clinical trial of lead candidate Bryostatin-1 for advanced Alzheimer’s disease.
The company expects to report three month interim data during the first quarter of 2017 with complete six month data set expected during the first half of 2017.
Charles S. Ramat, president and chief executive, told investors: "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,”
“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.
The study plans to enroll 150 patients at 30 US sites.
It 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.
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