Synaptogenix, Inc. today announced that it has completed enrolling its target of 100 patients for its ongoing National Institutes of Health (“NIH”) sponsored Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe Alzheimer’s disease (“AD”). The Company expects to announce topline data from the study during the fourth quarter of 2022.
Synaptogenix also reports that the independent Data Safety Monitoring Board (“DSMB”) overseeing the trial has confirmed the absence of any drug-related adverse safety issues.
Bryostatin-1 caused highly significant cognitive enhancement (4.0 SIB psychometric score above baseline) for the pre-specified patients who received Bryostatin-1 in the absence of Namenda in our two previous, consolidated 3-month pilot trials, recently published in a peer-reviewed article (JAD, 2022) – while the Placebo-treated patients showed no significant benefit. Bryostatin-1 treatment has now been extended to include double the number of doses (N = 14) in the current 6-month, placebo-controlled trial, in which randomized enrollment has been carefully controlled for balanced baselines in the treatment and placebo cohorts. Patients will have been observed for as long as three months after all dosing cessation, given the persistence of benefit for at least 30 days after dosing that was previously observed.
“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 pre-specified 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, the Company’s President and Chief Scientific Officer.
Alan Tuchman M.D., the Company’s Chief Executive Officer, stated, “Evidence is growing and continues to support Bryostatin-1 as a potential treatment for Alzheimer’s disease. 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.”