Pharma Focus America

Synaptogenix and Cleveland Clinic to Seek FDA Approval for Clinical Trial of Bryostatin-1 in Multiple Sclerosis

Thursday, July 20, 2023

Synaptogenix, Inc. (Nasdaq: SNPX), a biopharmaceutical company specializing in regenerative therapeutics for neurodegenerative disorders, has recently teamed up with Cleveland Clinic to conduct a phase 1 clinical trial of Bryostatin-1 in individuals with multiple sclerosis (MS). As part of the collaboration, Cleveland Clinic will be responsible for managing the clinical trial's implementation, including the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) and the recruitment of patients.

Dr. Robert Fox, the Vice-Chair for Research at Cleveland Clinic's Neurological Institute and the Principal Investigator for the Bryostatin-1 trial, expressed enthusiasm about examining the safety and potential activity of Bryostatin-1 on cognitive impairment in MS. He acknowledged that addressing cognitive impairment is a significant unmet need in the treatment of MS patients.

Dr. Alan Tuchman, the Chief Executive Officer of Synaptogenix, emphasized their commitment to advancing the clinical development of Bryostatin-1 for MS in collaboration with Cleveland Clinic. He noted that the upcoming trial would take place at Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis, a highly regarded institution known for its comprehensive MS care and research. Dr. Tuchman also mentioned that Synaptogenix is well-funded, with approximately $35.8 million in cash as of March 31, 2023, and a relatively low cash burn rate, providing ample resources for the clinical trial and other potential ventures.

Dr. Daniel Alkon, the President, and Chief Scientific Officer of Synaptogenix, highlighted the collaboration's focus on identifying a biomarker using advanced Magnetic Resonance Imaging (MRI) technology to evaluate Bryostatin-1's impact on the brain. Given the drug's potential mechanisms of action, including synaptic formation, anti-inflammatory properties, and potential for remyelination, Dr. Alkon suggested that Bryostatin-1 could potentially improve cognitive function in MS and address core aspects of the disease.

Bryostatin-1 is a small molecule known to activate protein kinase C, an enzyme crucial for maintaining synapse health and playing a role in learning and memory processes. Additionally, it may exert anti-inflammatory effects on the immune system. Preclinical studies have already shown promising results regarding Bryostatin's potential to address cognitive impairment in other neurodegenerative disorders, such as Alzheimer's disease, traumatic brain injury, and Fragile X syndrome. The upcoming clinical trial aims to investigate its potential to alleviate cognitive impairment in individuals with multiple sclerosis.

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