On 19 April, Synaptogenix, a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, announced that it has completed the enrolment of participants for its ongoing Phase IIb clinical trial of Bryostatin for people with advanced and moderately severe Alzheimer's disease (AD). The Phase 2b clinical trial is a 6-month randomised, double-blind and placebo-controlled study assessing safety, tolerability and long-term efficacy of Bryostatin in the treatment of moderately severe AD. Sponsored by the National Institutes of Health (NIH), the study has completed enrolling its target of 100 participants. Topline data from the study are expected during the fourth quarter of 2022.
In addition, the company reported that the independent Data Safety Monitoring Board (DSMB) overseeing the trial has confirmed the absence of any drug-related adverse safety issues. The two previous 3-months pilot trials demonstrated safety and significant cognitive enhancement for the participants who received Bryostatin, while the participants receiving placebo showed no significant benefit. Findings have recently been published in a peer reviewed article in the Journal of Alzheimer's Disease.