Synaptogenix President Daniel L. Alkon, M.D. Honored for Scientific Presentation at USC-Sponsored Forum on Age-Related Diseases and Neurodegenerative Disorders
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Insights
In a recent clinical trial, Synaptogenix, Inc. reported that its lead therapeutic candidate, Bryostatin-1, showed statistically significant benefits for patients with severe Alzheimer's disease (AD). Such findings are critical in the biopharmaceutical sector, as they suggest a potential new treatment path for a condition that currently has limited effective interventions.
The reported p-value of less than 0.007 indicates a strong statistical significance compared to placebo, which is likely to attract the attention of stakeholders, including investors and healthcare providers. The absence of cognitive decline during the 10-month study and the continuation of benefits post-treatment could imply a durable impact of the drug, a desirable outcome for long-term patient care and potentially, a competitive advantage in the market.
From an investment perspective, these results could influence the company's stock performance. Positive clinical outcomes can lead to increased investor confidence, potentially driving up stock prices. Moreover, advancements in AD treatment could address a significant unmet medical need, leading to substantial market opportunities for Synaptogenix.
The implications of Bryostatin-1's efficacy are profound in the context of neurodegenerative diseases. The activation of PKC epsilon – BDNF pathways is noteworthy, as these are involved in synaptic health and neuroprotection. The mention of the drug's synaptogenic, anti-apoptotic, anti-amyloid and anti-tau tangle properties aligns with current therapeutic targets in AD research, which focus on mitigating the pathological hallmarks of the disease.
Given the complex nature of AD, a drug that offers a multifaceted approach could be revolutionary. However, it is important to note that the transition from clinical efficacy to real-world effectiveness involves numerous hurdles, including regulatory approval processes, market competition and integration into clinical practice. Long-term, the potential success of Bryostatin-1 could pave the way for further investment in neurodegenerative disorder research and drug development.
The positive trial results for Bryostatin-1 position Synaptogenix at a pivotal point within the healthcare industry. The growing prevalence of AD and the lack of effective treatments make such advancements significant. If the drug proceeds to later-stage trials and eventually gains FDA approval, it could lead to a substantial increase in the company's market share and revenue.
It is crucial for stakeholders to consider the potential impact on healthcare costs and insurance coverage. A successful AD therapy could lead to increased healthcare spending but also offers the potential for cost savings through reduced long-term care needs. The balance between these factors will be a key consideration for payers and policymakers.
Investors should monitor the progression of Bryostatin-1 through subsequent trials and regulatory hurdles, as these will be critical in determining the drug's commercial viability and its impact on Synaptogenix's financial future.
Bryostatin-1 benefits in severe Alzheimer's disease patients were statistically significant with respect to placebo at p < 0.007
The award was presented by Giulio Maria Pasinetti, M.D., Ph.D., Saunders Family Chair and Professor of Neurology at the Icahn School of Medicine at
Dr. Alkon's presentation, titled "Chronic Alzheimer's Disease (AD) Patients Show Safe, Significant, and Persistent Benefit in 10-Month Bryostatin Trial," explored clinical data from the Company's NIH-sponsored, Phase 2 trial of its lead therapeutic candidate as a treatment for severe AD patients. In the trial, secondary efficacy endpoints were met with statistically significant benefits, p < 0.007, for severe AD patients. No significant cognitive decline was observed throughout the 10-month study, and persistent benefits continued at least 16 weeks beyond the final dosing.
Dr. Pasinetti commented, "We were thrilled that Dr. Alkon, recognized globally as a pioneer in research on brain-based neural networks, the molecular basis of memory and degenerative brain disorders, was able to join us and present at this conference. Dr. Alkon discussed how, in pre-clinical studies, Bryostatin-1, MW 904, an activator of PKC epsilon – BDNF pathways, demonstrated synaptogenic, anti-apoptotic, anti-amyloid, and anti-tau tangle efficacies…." Dr. Pasinetti noted, Bryostatin-1 has the potential to be a promising new treatment for Alzheimer's disease, with potential efficacy extending beyond chronic management to addressing the underlying neurodegenerative consequences of chronic AD progression.
IABS Forum-2023, held December 7-8, 2023 in
About Synaptogenix
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
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 anticipated Phase 1 trial of Bryostatin-1 in multiple sclerosis. 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 the Company 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
800-811-5591
ir@synaptogen.com
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SOURCE Synaptogenix, Inc.
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