Synaptogenix expecting data from its Phase 2 clinical trial of Bryostatin-1 for advanced Alzheimer’s disease in fourth quarter 2022
NEW YORK , Sept. 28, 2022 /PRNewswire/ — Synaptogenix, Inc. (Nasdaq: SNPX) (“Synaptogenix” or the “Company”), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today commented on the positive Phase 3 trial results for Lecanemab announced last night by Eisai and Biogen.
Dr. Daniel Alkon , President and Chief Scientific Officer of Synaptogenix, stated, “We continue to welcome the significant commitment that Biogen and Eisai are making towards developing a new treatment option for Alzheimer’s disease (AD). Synaptogenix shares the same commitment to treat AD, although the focus of Synaptogenix resources are toward the actual restoration of function and disease reversal, versus a singular focus on slowing the disease’s rate of clinical decline.
The Synaptogenix lead compound Bryostatin-1, 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/Eisai compound. Regeneration of brain wiring may result in actual improvement of patients’ cognitive performance, not just slowing of cognitive decline – as we reported for exploratory analyses of previous Bryostatin trial results in the Journal of Alzheimer’s Disease a few months ago. 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. We are excited to present our Phase 2 data during the fourth quarter of this year.”
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 database that will further inform clinical trial designs. Additional information about Synaptogenix, Inc. may be found on its website: www.synaptogen.com .
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.