Synaptogenix Discloses Positive Results of Further Bryostatin Trial Analyses in Presentation at Alzheimer's Association International Conference 2021
Synaptogenix, Inc. (SNPX) announced that its abstract titled "Bryostatin Restores Cognitive Functions Above Baseline in Advanced Alzheimer's Disease Patients" is now available for presentation at the Alzheimer's Association International Conference. The analysis indicates significant therapeutic efficacy of Bryostatin in advanced Alzheimer's patients, with a p-value of P<.001, showcasing an improvement of over +4.0 in Severe Impairment Battery scores. The company is also conducting a NIH-sponsored six-month clinical trial to further assess Bryostatin's effects.
- Significant therapeutic efficacy of Bryostatin with a p-value of P<.001 in advanced Alzheimer's patients.
- Improvement of > +4.0 in Severe Impairment Battery scores over baseline.
- NIH-sponsored six-month clinical trial underway for Bryostatin.
- None.
NEW YORK, July 26, 2021 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced that its abstract for presentation at the Alzheimer's Association International Conference (AAIC) is now available entitled "Bryostatin Restores Cognitive Functions Above Baseline in Advanced Alzheimer's Disease (AD) Patients: A Regenerative Therapeutic Strategy."
"Recent further analyses of pre-specified cohort results revealed clear evidence of Bryostatin therapeutic efficacy for advanced AD patients. Analyses of treatment benefit, based on mean differences and as a function of successive dosing in the Company's two previous, separate clinical studies (#202 and #203), used each patient as his / her own control in both treatment and placebo groups. While these separate analyses showed treatment benefit, the combined groups in a pooled analysis conducted here produced a highly significant statistical separation of the Bryostatin treatment group (P<.001) from the placebo group. Consolidation of identically enrolled and treated patients in the two clinical trials increased the power (N = 95) of pre-specified Treatment and Placebo groups with the resulting separation. This integrated data analysis provides further encouragement that Bryostatin can make a clinically meaningful difference for treating the underlying pathology and cognitive deterioration of AD – as is now being tested in an NIH-sponsored, six-month clinical trial, incorporating lessons learned from the two previous pilot studies. This potential efficacy involved significant improvement over baseline (> + 4.0 Severe Impairment Battery, SIB, score), not only reduction in the rate of cognitive decline," commented Dr. Daniel Alkon, President and Chief Scientific Officer.
The abstract can be accessed via the following link: https://www.synaptogen.com/wp-content/uploads/2021/07/ESCIOBAADP.pdf
Also, as previously announced, Synaptogenix will hold a conference call for investors to discuss its abstract. The call will take place, today, Monday, July 26th at 4:15pm ET and will be hosted by the Company's Chief Executive Officer, Dr. Alan Tuchman, and its President and Chief Science Officer, Dr. Daniel Alkon. Drs. Tuchman and Alkon will take live Q&A following their prepared remarks.
The U.S. toll free dial-in for the conference call is (877) 407-9205, and the international dial-in number is 1-(201)-689-8054. A live webcast of the conference call will also be available via: https://www.webcaster4.com/Webcast/Page/2599/42216.
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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