NEW
YORK, Dec. 16, 2022 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
regenerative therapeutics for neurodegenerative disorders, today
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."
Synaptogenix remains well-funded with approximately $38.5 million in cash as of December 15, 2022, or approximately $4.00 per share.1
About the NIH-Sponsored Phase 2
Trial
The 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 moderately
severe AD in the absence of memantine. The study was conducted with
financial support from the National Institute on Aging (NIA) and
the National Cancer Institute (NCI), both part of the National
Institutes of Health (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. These forward-looking statements include statements
regarding the Phase 2 clinical trial of Bryostatin-1 and further
studies, and continued development of use of Bryostatin-1 for AD
and other cognitive diseases. 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:
Investors:
800-811-5591
ir@synaptogen.com
1 Based on 7,267,032 shares of common stock
outstanding and 1,935,484 shares of common stock underlying
preferred stock convertible into shares of common stock at
$7.75 per share of common stock.
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SOURCE Synaptogenix, Inc.