Synaptogenix Advances Dosing of First Patient in Dose Optimization Clinical Trial in Preparation for NIH-Sponsored, Phase 2 Alzheimer's Disease Trial Data
Dose optimization prepares the Company for its next phase of Bryostatin clinical development
Company expects to announce topline data from its NIH sponsored Phase 2 clinical study during the fourth quarter of 2022
NEW YORK, July 20, 2022 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, announced today, in preparation for its next phase of Bryostatin clinical development, the dosing of its first patient in the Company's open-label dose optimization clinical trial.
Synaptogenix's therapeutic lead drug to treat Alzheimer's disease (AD), Bryostatin, recently showed a statistically significant improvement in the treatment group that was not observed in the placebo group in two pilot, placebo-controlled Phase 2 trials. (Thompson et al., JAD 2022). In the current 6-month trial, enrollment is complete and clinical testing is proceeding toward conclusion. The Company expects to announce topline data from its National Institutes of Health ("NIH") - sponsored, Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe AD during the fourth quarter of 2022.
"While the current dosing has been found to produce clear cognitive improvement over baseline, the Company has planned a dose-ranging study to optimize the extent and duration of benefits. With the encouraging data reported in our recent article, we want to be well positioned to conduct a registration study and to enter the clinic as soon as possible," stated Dr. Daniel Alkon, President and Chief Scientific Officer.
Alan Tuchman M.D., the Company's Chief Executive Officer, stated, "We continue to believe Bryostatin is uniquely positioned to target synaptic loss and are looking forward to announcing a read out of our Phase 2 topline data later 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 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.
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SOURCE Synaptogenix, Inc.
Company Codes: NASDAQ-NMS:SNPX