Synaptogenix Supports DEA's Cannabis Reclassification Proposal and Highlights Benefits for Cannasoul

Synaptogenix, Inc., a biopharmaceutical company specializing in treatments for neurodegenerative diseases, has expressed strong support for the U.S. Drug Enforcement Agency's (DEA) move to reclassify cannabis as a Schedule III drug. This shift, recommended by the U.S. Department of Health and Human Services, marks a significant change in cannabis policy, reversing nearly five decades of its Schedule I classification under the Controlled Substance Act. The reclassification is anticipated to ease the development and regulatory processes for cannabis-based therapeutics, potentially benefiting Synaptogenix's research partner, Cannasoul Analytics.

Cannasoul Analytics, established by the Technion-Israel Institute of Technology, focuses on discovering cannabis-based treatments. The proposed reclassification is expected to alleviate many of the regulatory hurdles currently faced by companies in the cannabis sector. It would allow for clearer, more efficient pathways for both non-clinical and clinical testing, eliminating the need for specialized licenses. Companies could then provide more accurate estimates regarding the costs and timelines of development. Additionally, access to manufacturing facilities and research sites for both animal and human testing would become more straightforward.

Dr. Alan Tuchman, CEO of Synaptogenix, expressed optimism about the potential changes, stating that the Schedule III classification would bring the development of cannabis-based drugs more in line with non-controlled substances. This alignment could mainstream clinical development, enhancing the value of Synaptogenix's assets and intellectual property. Synaptogenix’s collaboration with Cannasoul could thus leverage access to Technion-Israel Institute of Technology's resources to further their research.

The partnership between Synaptogenix and Cannasoul is investigating cannabis-based therapeutics for a variety of conditions, including solid tumors, migraines, inflammatory bowel disease, and estrogen-related illnesses. Clinical trials for these potential treatments are planned to take place in the United States.

In November 2023, Synaptogenix acquired a 25% stake in Cannasoul to bolster research in cannabinoid-based therapeutics. Cannasoul is renowned for its analytical method development in pharmaceutical and botanical research, particularly in analyzing over 100 cannabinoids and 100 terpenes. The Technion Research & Development Foundation, the commercialization wing of Technion-Israel Institute of Technology, founded Cannasoul, contributing significantly to Israel’s innovation economy.

Synaptogenix has a history of developing therapies for neurodegenerative diseases and has conducted extensive studies on its lead therapeutic candidate, Bryostatin-1. This candidate has shown promise in treating Alzheimer's disease and demonstrated regenerative mechanisms for conditions like Fragile X syndrome, multiple sclerosis, stroke, and traumatic brain injury. Bryostatin-1 has previously been tested in over 1,500 cancer patients, providing a substantial safety database that informs ongoing clinical trials. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Bryostatin-1 for treating Fragile X syndrome.

While Synaptogenix is enthusiastic about the potential regulatory changes, it acknowledges the risks and uncertainties inherent in drug development. Factors such as obtaining adequate financing, lengthy development timelines, regulatory hurdles, and market competition could impact the success of Bryostatin-1 and other therapeutic candidates.

Synaptogenix remains committed to its mission and is closely monitoring the developments regarding the DEA’s proposed cannabis reclassification, which could significantly influence the landscape of cannabis-based therapeutic research and development.