On 28 May 2020, Neurotrope, a company focused on developing drugs to treat neurodegenerative diseases including Alzheimer's disease (AD), announced the launch of a Phase II clinical trial to investigate the long-term use of Bryostatin-1 for the treatment of AD. The new study will be conducted in collaboration with the National Institutes of Health (NIH) under a USD 2.7 million grant. The company expects to enrol approximately 100 people with moderate and severe AD and to dose the first research participant later this year.
In September 2019, Neurotrope announced that the confirmatory Phase II clinical trial of Bryostatin-1, in moderate to severe AD, failed to meet its primary endpoint of change from baseline to week 13 in the Severe Impairment Battery (SIB) total score. In January 2020, the company reported that the study showed improvement in cognitive function, following completion of data analysis.
"We are very excited to advance Bryostatin-1 to its next phase of development. Given the high unmet need for new therapies to treat AD, recognised by the NIH and highlighted by their financial and scientific support, we plan to move this program forward as rapidly as possible, with the goal of demonstrating Bryostatin-1's potential benefit in this setting. Many other AD studies have been longer in duration than the studies we previously conducted” stated Dr Daniel Alkon, President and Chief Scientific Officer of Neurotrope.
