Synaptogenix Receives US FDA Approval of IND Application

Synaptogenix, Inc., a growing biopharmaceutical firm developing therapies for neurodegenerative disorders, announced that the Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for Bryostatin-1 as a possible treatment for multiple sclerosis (MS).

The Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis will host and oversee the fully funded open-label clinical trial. The study will use cutting-edge 7-tesla (7T) magnetic resonance imaging (MRI) technology to develop biomarkers for assessing Bryostatin-1's effects on the brain.

Robert Fox, M.D., Vice-Chair for Research, Neurological Institute, Cleveland Clinic, and principal investigator for the Bryostatin-1 trial commented, "Our study will apply state-of-the-art MRI technology together with behavioural and cognitive measures to evaluate treatment with investigational Bryostatin-1. Research and development of this drug could yield potential benefits for patients with MS."

"While cognitive decline is broadly recognized as a prevalent symptom of multiple sclerosis, the mechanisms underlying cognitive impairment remain obscure and inadequately studied in clinical trials," said Dr. Alan Tuchman, chief executive officer of Synaptogenix. "We seek to address this unmet need, with minimal expense, and look forward to launching our effort by enrolling/dosing our first patient in the near future."

Bryostatin-1 is a tiny molecule that promotes synapse health by activating protein kinase C (PKC) enzymes. It also plays a role in memory and learning. The therapy may also improve anti-inflammatory efficacy, helping to prevent the insulating sheath around nerve fibers from degrading.