Bryostatin-1 benefits in severe Alzheimer's
disease patients were statistically significant with respect to
placebo at p < 0.007
NEW
YORK, Sept. 26, 2023 /PRNewswire/
-- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
therapeutics for neurodegenerative disorders, today 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 Alzheimer's
disease. The paper, titled "Advanced Alzheimer's Disease (AD)
Patients Show Safe, Significant, and Persistent Benefit in 6 Month
Bryostatin Trial," will appear in the Journal of Alzheimer's
Disease later this month.
As stated in the paper, conclusions from analyses of
the trial's Severe Cohort indicate that 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. The paper goes on to discuss
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."
Dr. Alan Tuchman, Chief Executive
Officer of Synaptogenix, commented, "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."
Dr. 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."
About the Phase 2 Trial of Bryostatin-1
Synaptogenix's 6-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 #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.
About Synaptogenix
Synaptogenix is a clinical-stage biopharmaceutical company that
has historically worked to develop novel therapies
for neurodegenerative diseases. Synaptogenix has conducted
clinical and preclinical studies of its lead therapeutic candidate,
Bryostatin-1, in Alzheimer's disease. Preclinical studies have also
demonstrated bryostatin's regenerative mechanisms of action for the
rare disease Fragile X syndrome, and for other neurodegenerative
disorders such as multiple sclerosis, stroke, and traumatic brain
injury. The U.S. Food and Drug Administration has granted Orphan
Drug Designation to Synaptogenix for Bryostatin-1 as a treatment
for Fragile X syndrome. Bryostatin-1 has already undergone testing
in more than 1,500 people in cancer studies, thus creating a large
safety data base that will further inform clinical trial designs.
Additional information about Synaptogenix, Inc. may be found on its
website: www.synaptogen.com
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. Such forward-looking statements are subject to risks
and uncertainties and other influences, many of which the Company
has no control over. There can be no assurance that the clinical
program for Bryostatin-1 will be successful in demonstrating safety
and/or efficacy, that the Company will not encounter problems or
delays in clinical development, or that Bryostatin-1 will ever
receive regulatory approval or be successfully commercialized.
Actual results and the timing of certain events and circumstances
may differ materially from those described by the forward-looking
statements as a result of these risks and uncertainties. Additional
factors that may influence or cause actual results to differ
materially from expected or desired results may include, without
limitation, the Company's inability to obtain adequate financing,
the significant length of time associated with drug development and
related insufficient cash flows and resulting illiquidity, the
Company's patent portfolio, the Company's inability to expand its
business, significant government regulation of pharmaceuticals and
the healthcare industry, lack of product diversification,
availability of the Company's raw materials, existing or increased
competition, stock volatility and illiquidity, and the Company's
failure to implement its business plans or strategies. These and
other factors are identified and described in more detail in the
Company's filings with the Securities and Exchange Commission. The
Company does not undertake to update these forward-looking
statements.
Contact
800-811-5591
ir@synaptogen.com
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SOURCE Synaptogenix, Inc.