Synaptogenix Responds to FDA Approval of Aducanumab
Synaptogenix, Inc. (Nasdaq: SNPX) praised Biogen's FDA approval of Aducanumab for Alzheimer's treatment, emphasizing its commitment to innovative therapies for the disease. While acknowledging Biogen's efforts, Synaptogenix focuses on a restorative approach through its lead compound, Bryostatin-1, currently in an extended clinical trial. Bryostatin-1 is designed to regenerate brain synaptic networks and reduce amyloid levels. The company has previously conducted substantial studies on Bryostatin-1, establishing a robust safety database. The FDA has granted it Orphan Drug Designation for Fragile X syndrome.
- Biogen's Aducanumab approval underscores the need for Alzheimer's treatments, potentially increasing interest in Synaptogenix's Bryostatin-1.
- Synaptogenix's Bryostatin-1 is in an extended clinical trial, indicating progress in development.
- The company has established a large safety database from prior studies of Bryostatin-1, enhancing investor confidence.
- The forward-looking statements highlight significant risks and uncertainties regarding Bryostatin-1's clinical development and regulatory approval.
- Potential delays in clinical development could affect the timeline for Bryostatin-1's market introduction.
NEW YORK, June 7, 2021 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today issued a statement following the announced FDA approval of Biogen's new Alzheimer's treatment Aducanumab.
Daniel Alkon, M.D., President and Chief Scientific Officer, stated, "We applaud the significant commitment that Biogen has made towards developing a new treatment option for Alzheimer's Disease (AD). Their dedication and persistence to finding a therapy deserves acknowledgement and gratitude. Synaptogenix shares Biogen's commitment to treat AD, although the focus of Synaptogenix resources remains toward a restorative approach, actual restoration of function and disease reversal, versus that of only a slowing of the disease's rate of clinical decline. The Synaptogenix lead compound Bryostatin, now in an extended clinical trial, is believed to work on regeneration of brain wiring (synaptic networks), in addition to a reduction of amyloid that is targeted by the Biogen compound. We believe that innovative, potentially restorative, drug targets will add to the potential therapeutic benefits that FDA-approved medications must eventually offer to the millions of AD patients in the U.S. and abroad."
About Synaptogenix, Inc.
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
Investor Relations
Brett Maas
Hayden IR
brett@haydenir.com
(646)536-7331
Robert Weinstein
Chief Financial Officer
Synaptogenix, Inc.
rweinstein@synaptogen.com
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SOURCE Synaptogenix, Inc.
FAQ
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