Phase 2b Trial of Bryostatin-1 for Alzheimer Disease Completes Enrollment
The phase 2b clinical trial (NCT04538066) of bryostatin-1 (Synaptogenix, New York, NY) for individuals with advanced and moderately severe Alzheimer disease (AD) has completed enrollment with 100 participants.
In 2 previous consolidated pilot trials (NCT03560245) (NCT02431468), during a period of 3 months, participants who received bryostatin-1 in the absence of memantine scored above baseline for the Scale for Interpersonal Behavior (SIB), achieving highly significant cognitive enhancement. In the same trials participants treated with placebo showed no significant benefit.
"We are encouraged that the top line data due in the 4th quarter, 2022, will reflect the same or greater benefit already observed for patients in identical, previously treated prespecified cohorts in our previous phase 2a pilot trials. The absence of any drug-related adverse events, as have been observed with the few other therapeutic strategies reaching limited Food and Drug Administration (FDA) approval for AD, should facilitate our subsequent steps toward clinical utility. Benefits of at least 4.0 SIB scores, above baseline, are likely to be clinically meaningful, and therefore have the potential to treat the underlying disease as well as to provide symptomatic relief," stated Daniel Alkon, MD, Synaptogenix president and chief scientific officer.
In the pilot studies, participants received a cycle of 7 infusions over a 12-week period. In the phase 2b trial, 2 of these 12-week treatment cycles will be given, separated by a 30-day period. Participants in the phase 2b trial will also be observed for 3 months of dosing cessation based on previous observations that benefits of bryostatin may persist for 30 days after treatment.
Alan Tuchman MD, Synaptogenix chief executive officer, stated, "Evidence is growing and continues to support bryostatin-1 as a potential treatment for AD. We are excited today to announce the completion of our phase 2b enrollment and we are eagerly awaiting the read out of our top line data later this year."