The U.S. Food and Drug Administration (FDA) has cleared Find Therapeutics Inc.’s Investigational New Drug (IND) application for FTX-101, enabling the biopharmaceutical company to initiate its planned Phase 1 clinical study of FTX-101 in healthy volunteers.
 
FTX-101, find’s lead compound, is a first-in-class remyelinating agent that aims to restore vision in people suffering from Chronic Optic Neuropathy (CON).
 
“The FDA’s clearance of our IND marks an important achievement for Find, allowing us to proceed with our Phase 1 study of FTX-101, a potentially novel remyelination therapy under development for the treatment of Chronic Optic Neuropathy, or CON,” said Philippe Douville, CEO of Find. “We look forward to evaluating FTX-101 in Phase 1 clinical studies, bringing us a step closer to finding a solution for people suffering from CON for whom currently no approved therapy exists.”
 
The Phase 1 clinical trial is expected to be a single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate safety, tolerability, and pharmacokinetics of FTX-101 across different dose levels. The study is expected to enroll up to 80 participants.
 
The company anticipates the commencement of the study in Q4 2024.