Synaptogenix announces FDA approved IND application for Bryostatin-1

Synaptogenix announced that the FDA has authorized an Investigational New Drug, or IND, application for Bryostatin-1 as a potential treatment for multiple sclerosis, or MS. The fully-funded, open-label clinical trial will be held and managed at Cleveland Clinic Neurological Institute’s Mellen Center for Multiple Sclerosis. The study will utilize state-of-the-art 7-tesla magnetic resonance imaging, or MRI, technology to identify biomarkers for evaluating Bryostatin-1’s impact on the brain. Bryostatin-1 is a small molecule that works by activating protein kinase C, or PKC, enzymes required for maintaining synapse health and is involved in learning and memory. The therapy may also enhance anti-inflammatory efficacy to prevent degradation of the insulating sheath around nerve fibers. With a balance sheet including approximately $26.3M in cash as of March 31, the Company’s Phase 1 MS trial is fully-funded. The Company maintains a relatively low cash burn rate and ample resources to support continued development of Bryostatin-1 for MS and other indications, as well as to pursue research on other innovative assets and/or the potential acquisitions of asset rights.