Emerging biotech, Synaptogenix Inc., develops therapeutics for neurodegenerative disorders recently announced a peer-reviewed publication of ‘statistically significant’ integration of secondary and exploratory endpoint data from its previously completed phase 2 trial of Bryostatin-1 for AD.
The paper, ‘Advanced Alzheimer's Disease (AD) Patients Show Safe, Significant, and Persistent Benefit in 6 Month Bryostatin Trial,’ appears in the Journal of Alzheimer's Disease.
Conclusions published include analyses of the trial’s severe cohort that indicate Bryostatin-treated MMSE 10-14 patients showed no significant cognitive decline throughout the 10-month trial, compared with placebo patients' decline of -12.8 SIB points.
Synaptogenix said the paper discusses persistence in the data, stating, ‘the prolonged absence of any significant cognitive decline in Bryostatin-treated patients vs. placebo patients – even 16 weeks after the final dose of Bryostatin – suggests a long-lasting positive change in the treated patients' brains.’
Alan Tuchman , chief executive officer of Synaptogenix, said, "There is a huge unmet need in the AD population for drugs oriented specifically to advanced and severe patients. Approved drugs do exist for slowing decline in non-demented, Mild Cognitive Impairment (MCI) patients and possible early AD patients, but Bryostatin-1-treated Severe Cohort patients, in contrast, showed no significant cognitive decline across a 10-month span in our study.
“We believe that Bryostatin-1 for later-stage patients would be complementary to the early-stage AD drugs in providing a full range of treatment options for the more than six million Americans living with Alzheimer's disease.”
Synaptogenix's six-month 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 severe AD in the absence of memantine.
While moderate cohort patients showed no significant benefit, the data demonstrates that Bryostatin-1-treated patients in the severe cohort showed statistically significant improvement of cognitive performance over placebo patients for weeks 13 through to 42, with the last dose administered at week 26.
The study was conducted with financial support from the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both part of the NIH.
Daniel Alkon, president, and chief scientific officer, added, “We appreciate the acknowledgement from such an esteemed independent Alzheimer's journal. Persistence of real benefit at least 16 weeks beyond the final Bryostatin dosing is an extremely important outcome for Alzheimer's patients in the more advanced stages of the disease.”