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Synaptogenix, Cleveland Clinic seek US FDA approval to initiate phase 1 trial of Bryostatin-1 in multiple sclerosis

Synaptogenix, Inc., an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, announced that it entered into an agreement with Cleveland Clinic to conduct a phase 1 trial of Bryostatin-1 in multiple sclerosis (MS). Cleveland Clinic will manage the clinical trial's implementation, including an Investigational New Drug (IND) submission to the US Food and Drug Administration and patient enrollment.

"We look forward to working together to explore the safety and potential activity of Bryostatin-1 on cognitive impairment in multiple sclerosis," said Robert Fox , MD, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, and Principal Investigator for the Bryostatin-1 trial. "Cognitive impairment is a major unmet need in the treatment of people living with MS and we look forward to exploring the potential impact of this investigational drug."

Dr. Alan Tuchman, chief executive officer of Synaptogenix, added, "We are moving forward with our clinical development plans for Bryostatin-1 in MS in collaboration with Cleveland Clinic. The planned clinical trial will be held at Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis, one of the largest and most comprehensive programs for MS care and research worldwide. We do not believe that the elimination of synapses caused by MS has been addressed by any marketed drugs or drug strategies to date, and we believe this gap in MS treatment options presents a significant opportunity."

Dr. Tuchman continued, "With approximately $35.8 million in cash as of March 31, 2023, and a relatively low cash burn rate, Synaptogenix is well-funded with ample resources to continue its development of Bryostatin-1 for MS in collaboration with Cleveland Clinic, including initiation of the upcoming trial anticipated to commence in the fourth quarter of 2023.  As we move forward with this study, we will continue to pursue other potential business endeavours including the identification of other assets for clinical development."

Dr. Daniel Alkon, president and chief scientific officer of Synaptogenix, stated, "Cleveland Clinic, a leading provider of advanced Magnetic Resonance Imaging (MRI) technology for brain imaging, is collaborating with us to identify a biomarker that will evaluate Bryostatin-1's impact on the brain. Given the drug's putative restorative mechanisms of action, its potential unique ability to drive synaptic formation (regeneration), its anti-inflammatory activity, and its potential for remyelination (replacement of lost insulating sheath surrounding nerve cells), Bryostatin-1 may improve cognitive function in MS, and address other primary components of the disease."

Bryostatin-1 is a small molecule that works by activating protein kinase C, an enzyme required for maintaining synapse health, and involved in learning and memory. The therapy may also influence the immune system toward anti-inflammatory efficacy. Preclinical studies have already demonstrated Bryostatin's potential to address cognitive impairment in other neurodegenerative disorders such as Alzheimer's disease, traumatic brain injury, and Fragile X syndrome. MS may represent a new indication to ameliorate cognitive impairment.

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 US 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.