Find Therapeutics Gets FDA Nod for Phase 1 Study of FTX-101 for Chronic Optic Neuropathy

Find Therapeutics Inc., a biopharmaceutical firm specializing in innovative therapies for autoimmune disorders, has received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials for their new therapeutic agent, FTX-101. This milestone enables the company to evaluate FTX-101's safety in healthy volunteers starting in the fourth quarter of 2024.

Philippe Douville, CEO of Find Therapeutics, emphasized the significance of this development, stating, "The FDA's clearance of our IND is a crucial milestone for us. It allows us to advance to Phase 1 trials of FTX-101, a potentially groundbreaking therapy for Chronic Optic Neuropathy (CON). We are eager to assess the safety and tolerability of FTX-101, bringing us a step closer to a potential solution for patients suffering from CON, who currently have no approved treatments."

The Phase 1 trial will be structured as a single ascending dose (SAD) and multiple ascending dose (MAD) study. The primary aims are to evaluate the safety, tolerability, and pharmacokinetics of FTX-101 across varying dose levels. Up to 80 participants are expected to be enrolled in this study.

FTX-101, Find Therapeutics' lead compound, is a pioneering remyelinating agent designed to restore vision in individuals affected by Chronic Optic Neuropathy. This therapeutic peptide specifically targets Plexin A1 and Neuropilin 1, a receptor complex in the brain involved in the differentiation of oligodendrocyte precursor cells into myelinating oligodendrocytes. Preclinical studies using demyelinating models have shown promising results, demonstrating significant myelin repair activity.

Chronic Optic Neuropathy is a severe and debilitating condition characterized by the demyelination of the optic nerve and visual pathways in the brain. Although there are immunomodulatory drugs available that control inflammation and new relapses, they do not address the critical need for therapies that can repair damaged myelin to preserve axonal function and restore vision. Currently, CON affects approximately 90,000 individuals in the United States alone, highlighting the urgent requirement for effective and safe remyelination treatments.

Find Therapeutics was established in 2020 and focuses on developing next-generation therapies for inflammatory autoimmune diseases. The company was founded with investments from CTI Life Sciences, adMare BioInnovations, and Domain Therapeutics, alongside an exclusive license from Strasbourg University for a technology initially developed by Dr. Dominique Bagnard.

As the company prepares to launch its Phase 1 clinical trial, the biopharmaceutical community and patients suffering from CON will be watching closely for the outcomes of this study, which holds promise for a future where effective treatments for Chronic Optic Neuropathy are available.

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