Study will evaluate drug's potential
neuro-restorative mechanism(s) of action for improving
synaptic health and cognitive function in MS patients
NEW
YORK, July 19, 2023 /PRNewswire/ --
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the
"Company"), an emerging biopharmaceutical company developing
regenerative therapeutics for neurodegenerative disorders, today
announced that it entered into an agreement with Cleveland Clinic
to conduct a phase 1 trial of Bryostatin-1 in multiple sclerosis
(MS). Cleveland Clinic will manage
the clinical trial's implementation, including an Investigational
New Drug (IND) submission to the US Food and Drug Administration
and patient enrollment.
"We look forward to working together to explore the safety and
potential activity of Bryostatin-1 on cognitive impairment in
multiple sclerosis," said Robert
Fox, MD, Vice-Chair for Research, Neurological Institute,
Cleveland Clinic, and Principal Investigator for the Bryostatin-1
trial. "Cognitive impairment is a major unmet need in the treatment
of people living with MS and we look forward to exploring the
potential impact of this investigational drug."
Dr. Alan Tuchman, Chief Executive
Officer of Synaptogenix, added, "We are moving forward with our
clinical development plans for Bryostatin-1 in MS in collaboration
with Cleveland Clinic. The planned clinical trial will be held at
Cleveland Clinic Neurological Institute's Mellen Center for
Multiple Sclerosis, one of the largest and most comprehensive
programs for MS care and research worldwide. We do not believe that
the elimination of synapses caused by MS has been addressed by any
marketed drugs or drug strategies to date, and we believe this gap
in MS treatment options presents a significant opportunity."
Dr. Tuchman continued, "With approximately $35.8
million in cash as of March 31,
2023, and a relatively low cash burn rate, Synaptogenix is
well-funded with ample resources to continue its development of
Bryostatin-1 for MS in collaboration with Cleveland Clinic,
including initiation of the upcoming trial anticipated to commence
in the fourth quarter of 2023. As we move forward with this
study, we will continue to pursue other potential business
endeavors including the identification of other assets for clinical
development."
Dr. Daniel Alkon, President and Chief Scientific Officer of
Synaptogenix, stated, "Cleveland Clinic, a leading provider of
advanced Magnetic Resonance Imaging (MRI) technology for brain
imaging, is collaborating with us to identify a biomarker that will
evaluate Bryostatin-1's impact on the brain. Given the drug's
putative restorative mechanisms of action, its potential unique
ability to drive synaptic formation (regeneration), its
anti-inflammatory activity, and its potential for remyelination
(replacement of lost insulating sheath surrounding nerve cells),
Bryostatin-1 may improve cognitive function in MS, and address
other primary components of the disease."
Bryostatin-1 is a small molecule that works by activating
protein kinase C, an enzyme required for maintaining synapse
health, and involved in learning and memory. The therapy may
also influence the immune system toward anti-inflammatory
efficacy. Preclinical studies have already demonstrated
Bryostatin's potential to address cognitive impairment in other
neurodegenerative disorders such as Alzheimer's disease, traumatic
brain injury, and Fragile X syndrome. MS may represent a new
indication to ameliorate cognitive impairment.
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 anticipated Phase 1 trial of Bryostatin-1 in multiple
sclerosis. 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
View original
content:https://www.prnewswire.com/news-releases/synaptogenix-and-cleveland-clinic-to-submit-investigational-new-drug-ind-application-to-fda-for-clinical-trial-of-bryostatin-1-in-multiple-sclerosis-301880709.html
SOURCE Synaptogenix, Inc.
