Phase 1 study to assess safety of FTX-101, a therapeutic agent under development for regeneration of damaged myelin in Chronic Optic Neuropathy Company expects study to commence in Q4 2024 MONTREAL , Aug. 27, 2024 /PRNewswire/ - Find Therapeutics Inc., a biopharmaceutical company focused on the development of innovative therapies for autoimmune diseases, today announced that the U.
S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application for FTX-101, enabling the company to initiate its planned Phase 1 clinical study of FTX-101 in healthy volunteers. The company anticipates the commencement of the study in Q4 2024.
"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. About FTX-101 Find's lead compound, FTX-101, is a first-in-class remyelinating agent that.