Synaptogenix Announces Phase 2b NIH Sponsored Alzheimer's Disease Trial Update
- Data Safety Monitoring Board confirms Bryostatin-1 Safety
NEW YORK, June 9, 2021 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced an update on its ongoing National Institutes of Health ("NIH") sponsored Phase 2b clinical trial of Bryostatin-1 in patients suffering from moderately severe Alzheimer's disease ("AD"). To date, the Company has now dosed 58 of its target 100 patients. Seventeen sites continue to be live.
Additionally, the independent Data Safety Monitoring Board ("DSMB") overseeing the trial convened to assess the safety of Bryostatin through an interim analysis and confirmed that 40 advanced AD patients have been dosed with Bryostatin without any significant safety issues.
Alan Tuchman M.D., Chief Executive Officer, stated, "With the spotlight firmly on Alzheimer's disease following the recent FDA approval of Aducanumab, we are encouraged to see the level of evidence for Bryostatin-1 continues to grow. The DSMB assessment further validates the significant safety profile of Bryostatin, as opposed to safety issues observed with other candidate Alzheimer's drugs now being developed."
"Our two previous pilot trials demonstrated safety while also showing a 4.8 improvement over baseline of the Severe Impairment Battery Score. We are pleased that our ongoing six-month Phase 2b trial sponsored by the NIH, has also displayed signs of safety thus far, consistent with our two previous trials," stated Dr. Daniel Alkon, President and Chief Scientific Officer. "Efficacy and safety continue to be our primary objectives in the clinical trials of Bryostatin to treat advanced AD patients."
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.
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.
SOURCE Synaptogenix, Inc.
Company Codes: NASDAQ-NMS:SNPX