Collaborative study will evaluate drug's
potential to improve synaptic health and cognitive function in MS
patients
NEW
YORK, June 26, 2024 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
therapeutics for neurodegenerative disorders, today announced that
the Food & Drug Administration (FDA) has authorized an
Investigational New Drug (IND) application for Bryostatin-1 as a
potential treatment for multiple sclerosis (MS).
The fully-funded, open-label clinical trial will be held and
managed at Cleveland Clinic Neurological Institute's Mellen Center
for Multiple Sclerosis. The study will utilize
state-of-the-art 7-tesla (7T) magnetic resonance imaging
(MRI) technology to identify biomarkers for evaluating
Bryostatin-1's impact on the brain.
Robert Fox, M.D., Vice-Chair for
Research, Neurological Institute, Cleveland Clinic, and principal
investigator for the Bryostatin-1 trial commented, "Our study will
apply state-of-the-art MRI technology together with behavioral and
cognitive measures to evaluate treatment with investigational
Bryostatin-1. Research and development of this drug could yield
potential benefits for patients with MS."
"While cognitive decline is broadly recognized as a prevalent
symptom of multiple sclerosis, the mechanisms underlying cognitive
impairment remain obscure and inadequately studied in clinical
trials," said Dr. Alan Tuchman,
Chief Executive Officer of Synaptogenix. "We seek to address this
unmet need, with minimal expense, and look forward to launching our
effort by enrolling/dosing our first patient in the near
future."
Bryostatin-1 is a small molecule that works by activating
protein kinase C (PKC) enzymes required for maintaining synapse
health and is involved in learning and memory. The therapy may also
enhance anti-inflammatory efficacy to prevent degradation of the
insulating sheath around nerve fibers.
"Bryostatin-1 has been shown in preclinical studies, through its
activation of PKC enzymes, to prevent synapse loss and neuronal
death, to ameliorate inflammation, and reduce the onset of
neurologic deficits," added Daniel
Alkon, M.D., President and Chief Scientific Officer. "These
preclinical data suggest that Bryostatin-1 has promising potential
as a therapeutic agent for MS and perhaps more so for progressive
forms of MS."
With a strong balance sheet including approximately $26.3 million in cash as of March 31, 2024, the Company's Phase 1 MS trial is
fully-funded. The Company maintains a relatively low cash burn rate
and ample resources to support continued development of
Bryostatin-1 for MS and other indications, as well as to pursue
research on other innovative assets and/or the potential
acquisitions of asset rights.
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.