The study is designed to assess the safety, tolerability, and pharmacokinetics of FTX-101 to potentially treat chronic optic neuropathy. Credit: DuxX/Shutterstock.

The US Food and Drug Administration (FDA) has granted clearance for Find Therapeutics’ investigational new drug (IND) application to commence a Phase I trial of FTX-101, aimed at treating chronic optic neuropathy (CON).

The study is designed to assess the safety, tolerability, and pharmacokinetics of FTX-101 at varying dosage levels.

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It will also have single ascending dose (SAD) and multiple ascending dose (MAD) portions.

The Phase I trial is set to enrol up to 80 participants and will commence with healthy volunteers in fourth quarter (Q4) of this year.

A therapeutic peptide, FTX-101 acts on specific receptors, Plexin A1 and Neuropilin 1. This receptor complex in the brain has demonstrated to be linked to the oligodendrocyte precursor cell migration and differentiation into myelinating oligodendrocytes.

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The asset has demonstrated significant myelin restoration in preclinical models.

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Find Therapeutics CEO Philippe Douville said: “The FDA’s clearance of our IND marks an important achievement for Find, allowing us to proceed with our Phase I study of FTX-101, a potentially novel remyelination therapy under development for the treatment of chronic optic neuropathy, or CON.

“We look forward to evaluating FTX-101 in Phase I clinical studies, bringing us a step closer to finding a solution for people suffering from CON for whom currently no approved therapy exists.”

In June 2022, Find Therapeutics secured an exclusive global licence to develop a therapy from SATT Conectus for treating for multiple sclerosis (MS) and optic neuritis (ON).