Synaptogenix Gets US FDA Authorization of IND Application for Clinical Trial for Bryostatin-1

Synaptogenix Gets US FDA Authorization of IND Application for Clinical Trial for Bryostatin-1

By, Admin 2 July 2024

Synaptogenix gets US FDA authorization of IND application for clinical trial for Bryostatin-1 to treat multiple sclerosis

Overview

Synaptogenix, Inc., an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, announced that the Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) application for Bryostatin-1 as a potential treatment for multiple sclerosis (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 (7T) magnetic resonance imaging (MRI) technology to identify biomarkers for evaluating Bryostatin-1's impact on the brain.

Words from Cleveland Clinic

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.""

Words from CEO: Synaptogenix

  • 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.

About Bryostatin-1

  • Bryostatin-1 is a small molecule that works by activating protein kinase C (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.
  • Words from the chief scientific officer
  • Bryostatin-1 has been shown in preclinical studies, through its activation of PKC enzymes, to prevent synapse loss and neuronal death, to ameliorate inflammation, and reduce the onset of neurologic deficits,"" added Daniel Alkon, M.D., president and chief scientific officer. 
  • These preclinical data suggest that Bryostatin-1 has promising potential as a therapeutic agent for MS and perhaps more so for progressive forms of MS.

Trial funding

  • With a strong balance sheet including approximately $26.3 million in cash as of March 31, 2024, 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.

Synaptogenix

Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases.

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