Synaptogenix, Inc. announced topline data from its National Institute of Health (NIH)-sponsored Phase 2 clinical trial of Bryostatin-1 for the treatment of advanced Alzheimer's disease. The trial's primary endpoint of change from baseline in the Severe Impairment Battery (SIB) total score assessment obtained after completion of the second course of treatment (week 28) was not met with statistical significance. An average increase in the SIB total score of 1.4 points and 0.6 points was observed for the Bryostatin-1 and placebo groups, respectively, at week 28.

The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study comparing bryostatin-1 to placebo for long-term efficacy in the treatment of advanced and moderately severe AD in the absence of memantine. The study was conducted with financial support from the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both part of the National Institutes of Health (NIH). About SynaptogenixSynaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases.

Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease. Preclinical studies have also demonstrated Bryostatin's regenerative mechanisms of action for the rare disease Fragile X syndrome, and for other neurodegenerative disorders such as multiple sclerosis, stroke, and traumatic brain injury.