Find Therapeutics Inc, a Canada-based biopharmaceutical company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for FTX-101 to treat Chronic Optic Neuropathy (CON).
This approval allows the firm to start its proposed phase one clinical study of FTX-101 in healthy volunteers. It expects the study to begin in the fourth quarter of 2024.
The Phase one clinical trial is expected to be a single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and pharmacokinetics of FTX-101 across different dose levels. The study is intended to enrol up to 80 subjects.
Philippe Douville, Find CEO, said: "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. 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."
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