Incannex (IXHL) Healthcare announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration, FDA, previously reviewed and authorized the protocol to proceed under the Company’s Investigational New Drug, IND, application. The study will evaluate the efficacy and safety of IHL-42X, Incannex’s lead asset for the treatment of obstructive sleep apnea-a condition affecting an estimated one billion people globally with no approved oral pharmaceutical therapy. With the FDA authorization in place, Incannex will initiate Phase 3 immediately following the completion of Phase 2, leveraging a shared protocol and U.S. based infrastructure to maximize efficiency and speed.
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