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Synaptogenix Announces FDA Authorization of IND Application for Clinical Trial for Bryostatin-1 in Multiple Sclerosis

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Synaptogenix has received FDA authorization for an Investigational New Drug (IND) application to conduct a clinical trial on Bryostatin-1, a potential treatment for multiple sclerosis (MS).

The trial, which will be held at the Cleveland Clinic Neurological Institute's Mellen Center, aims to evaluate the drug's effects on synaptic health and cognitive function using advanced 7-tesla MRI technology.

Synaptogenix highlights the need to address cognitive decline in MS, with the trial fully funded and expected to start soon.

Preclinical data shows that Bryostatin-1 may enhance synapse health, reduce inflammation, and prevent neurological degradation.

Synaptogenix has a strong financial position with $26.3 million in cash, supporting ongoing and future research efforts.

Positive
  • FDA authorization for Bryostatin-1 clinical trial.
  • Fully funded Phase 1 trial for Bryostatin-1 in MS.
  • Collaboration with Cleveland Clinic for trial management.
  • Use of advanced 7-tesla MRI technology for biomarker identification.
  • Bryostatin-1 shows promising preclinical results in enhancing synapse health and reducing inflammation.
  • Strong financial position with $26.3 million in cash.
Negative
  • None.

From a clinical perspective, the FDA's authorization to proceed with the clinical trial of Bryostatin-1 for treating multiple sclerosis (MS) is a noteworthy development. Multiple Sclerosis is a chronic disease with no known cure, characterized by the immune system attacking the central nervous system, leading to a wide range of symptoms including cognitive decline. Bryostatin-1, with its mechanism of activating protein kinase C (PKC) enzymes, shows promise in addressing the synaptic health and cognitive function in MS patients. This could potentially translate into a significant therapeutic breakthrough if the clinical trials yield positive results.

It is important to understand that the transition from preclinical success to clinical effectiveness is fraught with challenges. Yet, given the complexity and the debilitating nature of MS, the advancements in therapeutic options could improve quality of life for many patients. Moreover, the use of advanced 7-tesla MRI technology to identify biomarkers represents a cutting-edge approach that could offer more precise data on the drug's efficacy.

For retail investors, the primary consideration would be the implications of these trials on Synaptogenix's market position and potential future revenues.

From a financial standpoint, Synaptogenix's announcement carries potential implications for its stock valuation. The authorization to commence a clinical trial by the FDA can act as a significant catalyst for a small-cap biopharmaceutical company like Synaptogenix. This could lead to increased investor interest and potential upward movement in share price due to the perceived advancement in their drug pipeline.

It is also important to note that the company has a solid balance sheet with approximately $26.3 million in cash as of March 31, 2024 and a fully funded Phase 1 trial for Bryostatin-1. This financial robustness, coupled with a relatively low cash burn rate, provides a strong foundation for the company to not only pursue this trial but also explore other innovative assets or potential acquisitions. For retail investors, the company's financial health and strategic positioning could indicate stability and potential for growth, albeit with the inherent risks associated with biotech investments.

From a market perspective, the entry of Bryostatin-1 into clinical trials for MS positions Synaptogenix in a competitive yet opportunity-laden segment within the biopharmaceutical industry. MS is a disease with significant unmet medical needs and a market projected to grow considerably over the next few years. If Bryostatin-1 demonstrates clinical efficacy, it could not only gain a substantial market share but also potentially become a first-in-class treatment due to its unique mechanism of action involving PKC enzymes.

This development could also attract attention from larger pharmaceutical companies in the form of partnerships or acquisitions, further validating Synaptogenix's strategic direction. However, investors should remain mindful of the high-risk, high-reward nature of investing in early-stage biotech companies, where clinical trial outcomes are uncertain and market success hinges on regulatory approvals and competitive dynamics.

Collaborative study will evaluate drug's potential to improve synaptic health and cognitive function in MS patients

NEW YORK, June 26, 2024 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that the Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) application for Bryostatin-1 as a potential treatment for multiple sclerosis (MS).

The fully-funded, open-label clinical trial will be held and managed at Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis. The study will utilize state-of-the-art 7-tesla (7T) magnetic resonance imaging (MRI) technology to identify biomarkers for evaluating Bryostatin-1's impact on the brain.

Robert Fox, M.D., Vice-Chair for Research, Neurological Institute, Cleveland Clinic, and principal investigator for the Bryostatin-1 trial commented, "Our study will apply state-of-the-art MRI technology together with behavioral and cognitive measures to evaluate treatment with investigational Bryostatin-1. Research and development of this drug could yield potential benefits for patients with MS."

"While cognitive decline is broadly recognized as a prevalent symptom of multiple sclerosis, the mechanisms underlying cognitive impairment remain obscure and inadequately studied in clinical trials," said Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix. "We seek to address this unmet need, with minimal expense, and look forward to launching our effort by enrolling/dosing our first patient in the near future."

Bryostatin-1 is a small molecule that works by activating protein kinase C (PKC) enzymes required for maintaining synapse health and is involved in learning and memory. The therapy may also enhance anti-inflammatory efficacy to prevent degradation of the insulating sheath around nerve fibers.

"Bryostatin-1 has been shown in preclinical studies, through its activation of PKC enzymes, to prevent synapse loss and neuronal death, to ameliorate inflammation, and reduce the onset of neurologic deficits," added Daniel Alkon, M.D., President and Chief Scientific Officer. "These preclinical data suggest that Bryostatin-1 has promising potential as a therapeutic agent for MS and perhaps more so for progressive forms of MS."

With a strong balance sheet including approximately $26.3 million in cash as of March 31, 2024, the Company's Phase 1 MS trial is fully-funded. The Company maintains a relatively low cash burn rate and ample resources to support continued development of Bryostatin-1 for MS and other indications, as well as to pursue research on other innovative assets and/or the potential acquisitions of asset rights.

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 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. 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

 

Cision View original content:https://www.prnewswire.com/news-releases/synaptogenix-announces-fda-authorization-of-ind-application-for-clinical-trial-for-bryostatin-1-in-multiple-sclerosis-302182860.html

SOURCE Synaptogenix, Inc.

FAQ

What is the purpose of the Synaptogenix clinical trial for Bryostatin-1?

The trial aims to evaluate Bryostatin-1's potential to improve synaptic health and cognitive function in multiple sclerosis patients.

Where will the Bryostatin-1 clinical trial be conducted?

The trial will be conducted at the Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis.

What technology will be used in the Bryostatin-1 clinical trial?

The trial will use state-of-the-art 7-tesla MRI technology to identify biomarkers.

How is the Bryostatin-1 clinical trial funded?

The Phase 1 trial is fully funded.

What are the preclinical findings for Bryostatin-1?

Preclinical data shows Bryostatin-1 may enhance synapse health, reduce inflammation, and prevent neurological degradation.

What is the financial status of Synaptogenix as of March 31, 2024?

Synaptogenix has approximately $26.3 million in cash, supporting ongoing and future research efforts.

Synaptogenix, Inc.

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