Phase 2 Bryostatin-1 Severe Cohort
secondary and exploratory endpoint data selected by independent
committee for presentation
NEW
YORK, July 13, 2023 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
regenerative therapeutics for neurodegenerative disorders, today
announced that an abstract featuring secondary endpoint data of its
National Institutes of Health (NIH) sponsored Phase 2 Bryostatin-1
trial was accepted for presentation at the 11th International Brain
Research Organization (IBRO) World Congress of Neuroscience to be
held in September 2023 in
Spain.
In the recently completed Phase 2 clinical trial of
Bryostatin-1, two cohorts were studied: a Moderate Cohort,
with MMSE* scores of 15-18, and a Severe Cohort,
with MMSE scores of 10-14. All patients were randomized with
respect to treatment groups, with safety checked by an independent
Data Safety Monitoring Board (DSMB). While Moderate Cohort patients
showed no significant benefit, for patients of the Severe Cohort,
representing the patient population with the most advanced
Alzheimer's disease (AD), nearly all pre-specified secondary
endpoints were achieved with statistical significance. Data
also showed statistical significance in exploratory secondary
endpoints for this Severe Cohort (MMSE 10-14 stratum), and post hoc
analysis was positive. Statistical significance in these
analyses was measured by patients' Severe Impairment
Battery* (SIB) changes from baseline for the Bryostatin-1
treatment group compared with the placebo group patients.
"We believe that our Phase 2 trial Severe Cohort results provide
evidence that Bryostatin-1 can prevent—not only slow—cognitive
decline in advanced AD patients. We are encouraged that our
abstract detailing this data has appealed to IBRO's standards for
the annual World Congress of Neuroscience," said Dr. Alan Tuchman, Chief Executive Officer of
Synaptogenix. "As we've stated previously, we are continuing to
evaluate the potential acquisition of new assets while also
exploring strategic non-dilutive investment partners to facilitate
continuing Bryostatin-1 development. Our primary focus continues to
be value creation for shareholders through our discovery of
restorative, novel therapeutics targeting life-altering
neurodegenerative diseases."
Dr. Daniel Alkon, President and Chief Scientific Officer of
Synaptogenix, commented: "Our trial data from the Severe
Cohort patients support the potential use of Bryostatin-1 to
prevent cognitive decline in severe AD patients. As opposed to
recently approved Alzheimer's drugs, such as lecanemab, aduhelm,
and donanenemab, which focus on early-stage dementia and mild
cognitive impairment (MCI) and have been shown to only slow those
conditions, we are working in a more severe disease cohort and have
developed data that we believe indicates that severe Alzheimer's
deterioration can be prevented. If further confirmed, our
Bryostatin-1 therapeutic could significantly address a huge unmet
medical need to both reduce and potentially prevent the underlying
progression of advanced AD, without significant side effects."
"We are pleased that the IBRO World Congress has recognized our
findings on the cognitive benefits of Bryostatin-1 for advanced and
severe AD patients. By addressing synapse dysfunction, Bryostatin
goes to the root of cognitive loss in AD. If future trials confirm
that progression is blocked by Bryostatin, these findings
could form the basis of new therapeutic treatments," said Dr.
George Perry, Synaptogenix
Scientific Advisory Board Chairman.
As of March 31, 2023, Synaptogenix
maintains a clean capital structure and strong cash position of
$35.8 million.
About the IBRO World Congress
In collaboration with neuroscience societies around the globe,
IBRO holds international congresses once every four years to
promote the field of neuroscience, increase awareness about
neuroscience research and facilitate collaboration between
researchers from all over the world. To facilitate the
international participation, the Congress venues alternate from
region to region.
In 2023, the Spanish Neuroscience
Society (SENC, Sociedad Española de Neurociencia) will host
the 11th IBRO World Congress of Neuroscience at the
Granada Exhibition and Conference Centre (Palacio de Exposiciones y
Congresos de Granada) from September
9th thru 13th, 2023.
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. 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
800-811-5591
ir@synaptogen.com
* Mini-Mental State Examination, the most commonly used
instrument for screening cognitive function.
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SOURCE Synaptogenix, Inc.