Incannex Healthcare Inc. (IXHL) has received FDA authorization to proceed with the Phase 3 stage of its RePOSA clinical trial, assessing IHL-42X, its lead drug candidate for obstructive sleep apnea - OSA.
This condition affects approximately one billion people globally and currently lacks an approved oral therapy.
The Phase 3 trial will commence in the U.S. immediately after Phase 2 concludes, utilizing the same infrastructure and vendors to enhance speed and reduce costs. Around 20 existing U.S. trial sites will continue, with 10 more to be added. The trial will last 12 months and evaluate IHL-42X's safety and efficacy against both placebo and its individual drug components—dronabinol and acetazolamide.
CEO Joel Latham emphasized the significance of this milestone, stating that IHL-42X could be the first FDA-approved oral treatment for OSA, positioning Incannex for strong commercial impact. He noted the streamlined U.S.-only design and retained operational continuity as key advantages, with Phase 2 topline data expected soon.
Thursday, IXHL closed at $0.22, down 4.39%, before rising 1.77% in after-hours trading to close at $0.2239 on the NasdaqGM.
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