Synaptogenix, Inc. (Nasdaq: SNPX) ("the Company"), a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that its peer-reviewed scientific manuscript entitled, "Bryostatin Placebo-Controlled Trials Indicate Cognitive Restoration Above Baseline for Advanced Alzheimer's Disease ("AD") in the Absence of Memantine" was published in the Journal of Alzheimer's Disease. The article documents evidence from two placebo-controlled trials that Bryostatin-1 improved cognition over baseline of advanced AD patients.
"Rigorous statistical analyses, including a pooled testing of identical pre-specified cohorts in two separate trials, revealed highly significant (p<.001) benefit of Bryostatin-1 treatment of AD patients in the absence of the dementia treatment memantine. Blinded placebo controls in these trials allow for the exclusion of the placebo effects that so often accompany early testing of candidate drugs to treat AD," stated Dr. Daniel Alkon, MD, President and Chief Scientific Officer. "Importantly, we believe that the peer-reviewed data in our manuscript has provided additional justification for our continued grant support from the National Institutes of Health ("NIH") for our ongoing Phase 2b clinical trial."
Alan Tuchman, M.D., Chief Executive Officer, commented, "The power of these results, enhanced by appropriate pooling of pre-specified cohorts, provides encouragement that our six-month trial will confirm Bryostatin-1's effective treatment of the underlying degenerative progression of AD – a claim that other therapeutic strategies have struggled to demonstrate to date."
About Synaptogenix, Inc.
Synaptogenix is a clinical-stage biopharmaceutical company discovering restorative, novel therapeutics for patients with life-altering neurodegenerative diseases and developmental disorders. Synaptogenix is currently conducting a National Institutes of Health-supported Phase 2b clinical trial of its lead therapeutic candidate Bryostatin-1 in patients suffering from moderately to severe Alzheimer's disease. In addition to AD, preclinical studies have demonstrated Bryostatin-1's regenerative mechanisms of action for the rare disease Fragile X syndrome, and the U.S. Food and Drug Administration has granted the drug Orphan Drug Designation for this indication. Other potential indications include multiple sclerosis ("MS"), stroke, and traumatic brain injury. Bryostatin has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety database that will further inform clinical trial designs. www.synaptogen.com
