Core Viewpoint - Synaptogenix, Inc. has received FDA authorization for an Investigational New Drug application for Bryostatin-1, aimed at treating multiple sclerosis (MS) [1][3]. Group 1: Clinical Trial Details - A fully-funded, open-label clinical trial will be conducted at the Cleveland Clinic Neurological Institute's Mellen Center for MS, utilizing advanced 7-tesla MRI technology to assess biomarkers related to Bryostatin-1's effects on the brain [2]. - The trial will incorporate behavioral and cognitive measures to evaluate the treatment's efficacy [3]. Group 2: Mechanism and Potential Benefits - Bryostatin-1 activates protein kinase C (PKC) enzymes, which are essential for synapse health and cognitive functions, potentially enhancing anti-inflammatory effects to protect nerve fibers [3][4]. - Preclinical studies indicate that Bryostatin-1 may prevent synapse loss, neuronal death, and reduce neurological deficits, suggesting its promise as a therapeutic agent for MS, particularly progressive forms [4]. Group 3: Financial Position - As of March 31, 2024, Synaptogenix has approximately $26.3 million in cash, ensuring full funding for the Phase 1 MS trial and supporting ongoing development of Bryostatin-1 and other innovative assets [4].
Synaptogenix Announces FDA Authorization of IND Application for Clinical Trial for Bryostatin-1 in Multiple Sclerosis