Synaptogenix Announces Phase 2b Bryostatin-1 Clinical Trial Update
Synaptogenix, Inc. (OTC: SNPX) has provided an update on its Phase 2b clinical trial of Bryostatin-1 for moderately severe Alzheimer's disease. The trial has dosed 43 out of 100 targeted patients across 17 sites, with no safety issues reported. The trial aims for two 11-week dosing cycles and seeks to replicate a previous improvement of 4.8 Severe Impairment points. The CEO noted that enrollment is on track despite potential COVID-19 impacts, emphasizing a structured trial duration to mitigate placebo effect risks.
- Initiation of dosing for 43 out of 100 patients in Phase 2b trial.
- No reported safety issues or imbalances in the treatment groups.
- Trial aims to extend significant improvements seen in prior studies.
- None.
NEW YORK, April 1, 2021 /PRNewswire/ -- Synaptogenix, Inc. (OTC: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced an update on its ongoing National Institute 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 dosed 43 of its target 100 patients. Seventeen sites are currently live. The monitoring of the balance between the placebo group and the drug group has been completed on a blinded basis by an independent review and there have been no imbalances or safety issues referable to Bryostatin-1 reported thus far.
"By including two 11-week cycles of Bryostatin-1 dosing, in the absence of Namenda, we hope to confirm and extend the significant improvement of 4.8 Severe Impairment points (SIB) over baseline already observed with each single 11-week cycle in two prior pilot Phase 2 clinical trials for advanced AD patients," stated Dr. Daniel Alkon, President and Chief Scientific Officer.
Alan Tuchman M.D., Chief Executive Officer, commented, "Despite concerns that Covid-19 might interfere with our trial progress, we are on schedule and enrolling well. By having adequate safeguards against baseline imbalance and a more conventional six-month duration trial, we expect to avoid any issues with placebo effects. We look forward to sharing further updates on this trial when available."
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
What is the purpose of the Phase 2b clinical trial for SNPX's Bryostatin-1?
How many patients have been dosed in the Bryostatin-1 trial as of the latest update?
What were the results of the previous pilot studies for Bryostatin-1?
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