On 9 September, Neurotrope, a company focused on developing drugs to treat neurodegenerative diseases including Alzheimer's disease (AD), announced top-line results from its confirmatory Phase II study of Bryostatin-1, an investigational treatment for moderate to severe Alzheimer disease (AD). This potent modulator of protein kinase C could stimulate synaptic growth factors, amyloid-beta degrading enzymes, and prevent Tau transformation into neurofibrillary tangles.
The confirmatory Phase II clinical trial was designed to assess the safety and efficacy of Bryostatin-1 in people with moderate to severe AD not receiving memantine treatment. Participants were randomised to receive 20μg of Bryostatin-1 or placebo over 12 weeks.
The company reported that its Phase II study of Bryostatin-1 failed to meet its primary endpoint of change from baseline to week 13 in the Severe Impairment Battery (SIB) total score. Similarly, Bryostatin-1 did not show any significant difference in the secondary outcome measures, which were changes from baseline to week 5, 9 and 15 in the SIB total score. Neurotrope is conducting a full review of the data.
