The US Food and Drug Administration (FDA) has granted authorisation for an investigational new drug (IND) application of Synaptogenix to commence a clinical trial of Bryostatin-1 for potentially treating multiple sclerosis.

The fully-funded, open-label trial will be conducted and handled at the Cleveland Clinic Neurological Institute’s Mellen Center for Multiple Sclerosis.

To detect biomarkers and assess Bryostatin-1’s effects on the brain, the study will leverage 7-tesla (7T) magnetic resonance imaging (MRI) technology.

A small molecule, Bryostatin-1 is designed to activate protein kinase C enzymes, which are crucial for synaptic health and associated with cognitive functions such as learning and memory.

Additionally, the therapy has potential anti-inflammatory properties to protect the nerve fibres’ insulating sheath.

Synaptogenix CEO Dr Alan Tuchman said: “While cognitive decline is broadly recognised as a prevalent symptom of multiple sclerosis, the mechanisms underlying cognitive impairment remain obscure and inadequately studied in clinical trials.

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“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.”

With a robust financial position, including about $26.3m in cash as of 31 March this year, Synaptogenix’s Phase I MS trial is fully funded.

The company also noted that it has a relatively low cash burn rate, ensuring sufficient funds to further develop Bryostatin-1 for MS and other conditions, and to explore additional innovative assets or potential acquisitions.

Synaptogenix president and chief scientific officer Daniel Alkon said: “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.

“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.”