Proposed Schedule III drug classification expected to de-risk Cannasoul's cannabis research and potential regulatory pathways
NEW YORK, May 7, 2024 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today applauds the reported move by the U.S. Drug Enforcement Agency (the "DEA") to recommend reclassifying cannabis as a Schedule III drug, and announces potential benefits of the rescheduling to its partner Cannasoul Analytics ("Cannasoul"), founded by the Technion-Israel Institute of Technology, in its discovery of cannabis-based therapeutics.
As reported in the press on April 30, 2024, the DEA will move to reclassify cannabis from a Schedule I drug to a Schedule III under the Controlled Substance Act on recommendation by the U.S. Department of Health and Human Services. The reclassification would be the most significant change in cannabis policy in 50 years. The rescheduling of cannabis would significantly de-risk drug development for cannabis and derivatives and enable companies to utilize well-defined pathways for non-clinical and clinical testing, without specialized license requirements. Reclassification would also enable cannabis drug developers to provide straightforward estimates on timing and costs through easier access to manufacturing facilities and research sites for animal and human testing.
"We are pleased to learn about the DEA's proposed rescheduling, which, if adopted as a final rule pursuant to the typical rulemaking process, we believe would bring substantial benefits for drug discovery companies engaged in clinical development for cannabis-based therapeutics," said Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix. "Schedule III classification would more closely align clinical development for such therapies with the regulatory pathways for non-controlled drugs. As clinical development becomes more mainstream, we believe our partnership with Cannasoul has the potential to unlock even greater value from owned assets and intellectual property as well as our accessibility to the resources of Cannasoul's founder, the Technion-Israel Institute of Technology."
The partnership with Cannasoul is exploring potential targets for cannabinoid-based therapeutics in multiple indications including solid tumors, migraine headache, inflammatory bowel disease, and estrogen-related diseases. Any future clinical development program involving any such targets is expected to be conducted in the United States.
About the Synaptogenix/Cannasoul Partnership
Synaptogenix acquired a 25% stake in Cannasoul in November 2023 in support of research and development cannabinoid-based therapeutics. Cannasoul is known in the field of analytical method development for pharmaceutical and botanical research and development, and it holds unique expertise in the field of cannabis and psilocybin research through its analysis of more than 100 cannabinoids and 100 terpenes. Cannasoul is founded by the Technion Research & Development Foundation, the commercialization arm of the Technion-Israel Institute of Technology, Israel's largest center of applied research and a major source of innovation driving the Israeli economy.
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.
