Dose optimization prepares the Company for its
next phase of Bryostatin clinical development
Company expects to announce topline data from its
NIH sponsored Phase 2 clinical study during the fourth quarter of
2022
NEW
YORK, July 20, 2022 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
regenerative therapeutics for neurodegenerative disorders,
announced today, in preparation for its next phase of Bryostatin
clinical development, the dosing of its first patient in the
Company's open-label dose optimization clinical trial.
Synaptogenix's therapeutic lead drug to treat Alzheimer's
disease (AD), Bryostatin, recently showed a statistically
significant improvement in the treatment group that was not
observed in the placebo group in two pilot, placebo-controlled
Phase 2 trials. (Thompson et al., JAD 2022). In the current 6-month
trial, enrollment is complete and clinical testing is proceeding
toward conclusion. The Company expects to announce topline data
from its National Institutes of Health ("NIH") - sponsored, Phase
2b clinical trial of Bryostatin-1 for
patients suffering from advanced and moderately severe AD during
the fourth quarter of 2022.
"While the current dosing has been found to produce clear
cognitive improvement over baseline, the Company has planned a
dose-ranging study to optimize the extent and duration of
benefits. With the encouraging data reported in our recent
article, we want to be well positioned to conduct a registration
study and to enter the clinic as soon as possible," stated Dr.
Daniel Alkon, President and Chief
Scientific Officer.
Alan Tuchman M.D., the Company's
Chief Executive Officer, stated, "We continue to believe Bryostatin
is uniquely positioned to target synaptic loss and are looking
forward to announcing a read out of our Phase 2 topline data later
this year."
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 we 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 information:
Investors and Media
800-811-5591
ir@synaptogen.com
Robert Weinstein
Chief Financial Officer
Synaptogenix, Inc.
rweinstein@synaptogen.com
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SOURCE Synaptogenix, Inc.