- Announces encouraging secondary endpoint results from
NIH-sponsored Phase 2 clinical trial of Bryostatin-1 in advanced
Alzheimer's disease patients
- Maintains strong financial position with approximately
$37.5 million in cash as of
December 31, 2022
- Exploring opportunities which may include acquiring rights
to new assets; continuing collaborative research with strategic
partners
NEW
YORK, March 7, 2023 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
regenerative therapeutics for neurodegenerative disorders, today
provided a corporate update and announced encouraging results of
its analysis of secondary endpoints and post hoc analysis from its
National Institute of Health ("NIH") - sponsored Phase 2 extended
clinical trial evaluating the safety, tolerability, and long-term
efficacy of Bryostatin-1 for the treatment of advanced Alzheimer's
disease (AD).
Dr. Alan Tuchman, Synaptogenix
Chief Executive Officer, stated, "Senior management and our Board
of Directors have concluded an exploratory review of our business
operations. With encouraging results from our secondary,
exploratory, and post hoc analysis of our Phase 2 Bryostatin-1
trial results, we are continuing to evaluate next steps and will
seek a validating third party strategic and non-dilutive investment
partner to move forward with that program. In the meantime, we
continue to evaluate the use of Bryostatin-1 with our previously
announced strategic partners for additional indications, Cleveland
Clinic and Nemours A.I. DuPont Hospital. Additionally, Synaptogenix
remains well-funded with approximately $37.5
million in cash as of year-end 2022 and a relatively low
cash burn rate, which could support a potential acquisition of
asset rights or funding trials for other assets. As we evaluate
these business opportunities, our primary focus is creating
shareholder value, and we look forward to updating our investors on
our new initiatives in the near term."
Phase 2 Bryostatin-1 Trial: Secondary and Exploratory
Endpoints, Post Hoc Analysis
Synaptogenix Scientific Advisory Board Chair Dr. George Perry commented, "The secondary
endpoints, together with post hoc analysis of this trial and the
results of the previous trials, show material consistency in the
MMSE-2 10-14 stratum, indicating that there may be continued
promise for the use of Bryostatin-1 for the segment of the
Alzheimer's patient population with the most advanced cases of the
disease."
As previously announced, the Phase 2 Bryostatin-1
trial's primary endpoint of change from baseline in the SIB
(Severe Impairment Battery) total score assessment obtained after
completion of the second course of treatment (week 28) was not met
with statistical significance. In the secondary endpoint analysis,
changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB
total score were not statistically significant in the total patient
population, and no pre-specified secondary endpoints* were met with
statistical significance in the low-to-moderately severe AD patient
stratum. However, nearly all pre-specified secondary endpoints in
the most advanced and severe AD (MMSE: 10-14) patient population,
with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition)
scores of 10-14, were achieved with statistical significance (p =
<0.05, 2-tailed). Data also showed statistical significance in
exploratory secondary endpoints for the MMSE-2 10-14 stratum, and
post hoc analysis was positive.
Secondary efficacy endpoints met with statistical significance
(MMSE-2 10-14 stratum):
- Changes from baseline at weeks 20, 24, and 30 in the SIB total
score.
Exploratory endpoint met with statistical significance (MMSE-2
10-14 stratum):
- Change from baseline in MMSE-2 total score at week 42.
Post hoc analysis:
- Treatment differences from the baseline SIB total score for the
MMSE-2 10-14 stratum confirmed statistical significance at weeks
13, 15, 28, and 42 using Bryostatin-1.
- Trend analysis of the MMSE-2 10-14 stratum was also
statistically significant.
"Our latest statistically significant results for the severe AD
patient stratum (MMSE 10 -14) reinforce the observed clinical
benefit for this same severe stratum in our two previous, shorter
duration Phase 2 Bryostatin-1 trials. I believe these data provide
promising evidence that Bryostatin-1 can prevent – not only slow –
cognitive decline in advanced AD patients," stated Dr. Daniel Alkon, President and Chief Scientific
Officer.
About the NIH-Sponsored Phase 2 Clinical Trial
The Phase 2 clinical trial was a randomized, double-blind,
placebo-controlled study comparing 6 months' 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.
* MMSE-2 scores of 10-14 and 15-18 were the only pre-specified
secondary analysis of the separate MMSE strata in the trial.
Contact:
Investors:
800-811-5591
ir@synaptogen.com
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SOURCE Synaptogenix, Inc.