Monday, April 29, 2024

Synaptogenix Moves Forward with Clinical Development Plans for Bryostatin-1 as a Treatment for Multiple Sclerosis

Synaptogenix, Inc., a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, announced plans to develop Bryostatin-1 for the treatment of multiple sclerosis (“MS”), a third indication for the drug candidate. The Company will collaborate with the Cleveland Clinic through a new consulting agreement.

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Synaptogenix is excited to work with this internationally recognized team of experts. A clinical trial focused on both safety and efficacy is the priority of the collaboration. Advancing our clinical development plans through partnership has been a strategic focus over the past year and will continue to be a key focus going forward. We are very pleased that we’ve been able to partner with world leading institutions on endeavors such as this collaboration with Cleveland Clinic for MS and our previously announced Fragile X partnership with Nemours A. I. Dupont,” stated Dr. Alan Tuchman, CEO of Synaptogenix, Inc.

“Multiple sclerosis joins Alzheimer’s disease (“AD”) and Fragile X syndrome as our third indication with potential clinical benefit from Bryostatin-1. Elimination of synapses in MS patients, like those lost in AD, has not been addressed by currently available drug strategies. Through its synaptogenic, restorative mechanisms of action, we believe that Bryostatin-1 is uniquely positioned to target synaptic loss and cognitive dysfunction in MS, and potentially other aspects of the disease such as inflammation and demyelination. We will work with the Cleveland Clinic to finalize a protocol as soon as possible with the goal of moving towards a clinical trial soon thereafter,” stated Dr. Daniel Alkon, the Company’s President and Chief Scientific Officer.

About Synaptogenix, Inc.

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.

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