FDA grants IND approval for Finds Phase I optic neuropathy trial

The aim of the study is to investigate the safety, tolerability and pharmacokinetics of FTX-101 for the potential treatment of chronic optic neuropathy. Image credit: DuxX/Shutterstock.

The U.S. Food and Drug Administration (FDA) has approved Find Therapeutics’ Investigational New Drug (IND) application to initiate a Phase I trial of FTX-101 for the treatment of chronic optic neuropathy (CON).

The aim of the study is to investigate the safety, tolerability and pharmacokinetics of FTX-101 at different doses.

There will also be single ascending dose (SAD) and multiple ascending dose (MAD) portions.

The Phase I trial is expected to enroll up to 80 participants and will begin in the fourth quarter (Q4) of this year with healthy volunteers.

FTX-101, a therapeutic peptide, acts on specific receptors, Plexin A1 and Neuropilin 1. This receptor complex in the brain has been shown to be associated with the migration of oligodendrocyte precursor cells and differentiation into myelinating oligodendrocytes.

The drug has demonstrated significant myelin restoration in preclinical models.

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive advantage.

Company profile – free sample

Your download email will arrive shortly

We are confident in the unique quality of our company profiles, but we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by filling out the form below.

By GlobalData

Check this box to stop receiving curated industry news, reports and event updates from Clinical Trials Arena.

For more information about our Services, how we use, process and share your personal data, including information about your rights in relation to your personal data and how to unsubscribe from future marketing communications, please see our Privacy Policy. Our Services are aimed at corporate subscribers and you warrant that the email address provided is your corporate email address.

Philippe Douville, CEO of Find Therapeutics, said: “The approval of our IND by the FDA represents an important achievement for Find and allows us to proceed with our Phase I study of FTX-101, a potentially novel remyelination therapy currently in development for the treatment of chronic optic neuropathy (CON).

“We look forward to evaluating FTX-101 in Phase I clinical trials, bringing us one step closer to finding a solution for people with CON who currently have no approved therapy.”

In June 2022, Find Therapeutics secured an exclusive worldwide license to develop a SATT Conectus therapy for the treatment of multiple sclerosis (MS) and optic neuritis (ON).