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Synaptogenix Announces Topline Results from NIH-Sponsored Phase 2 Clinical Trial of Bryostatin-1 for Advanced Alzheimer’s Disease
Synaptogenix, an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, has 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.
“We are disappointed in the topline results from this Phase 2 trial. Having just received the primary endpoint data, we are conducting a full review of all of the trial data to determine potential next steps and will provide an update of our plans when appropriate. We are committed to creating value for our shareholders and our substantial balance sheet offers us flexibility as we determine the next steps forward,” said Synaptogenix Chief Executive Officer Alan Tuchman, M.D. “We are grateful to the study participants, investigators, the National Institutes of Health, and our distinguished advisors for their important contributions.”
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