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Incannex Healthcare | 8-K: Current report

SEC announcement ·  Jan 17 00:00
Summary by Moomoo AI
On January 17, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the approval of its Phase 2/3 clinical trial protocol by an Institutional Review Board (IRB). The trial is designed to evaluate the safety and efficacy of IHL-42X, a proprietary combination drug candidate for patients with obstructive sleep apnea (OSA). The RePOSA study, which is the name of the trial, will include a four-week Phase 2 dose ranging trial to determine the optimal dose of IHL-42X, followed by a 52-week Phase 3 trial comparing this optimal dose against the component APIs and placebo. The study aims to recruit at least 560 patients and will be conducted across multiple sites in the United States and Europe. This follows a successful Phase 2 proof-of-concept study where...Show More
On January 17, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the approval of its Phase 2/3 clinical trial protocol by an Institutional Review Board (IRB). The trial is designed to evaluate the safety and efficacy of IHL-42X, a proprietary combination drug candidate for patients with obstructive sleep apnea (OSA). The RePOSA study, which is the name of the trial, will include a four-week Phase 2 dose ranging trial to determine the optimal dose of IHL-42X, followed by a 52-week Phase 3 trial comparing this optimal dose against the component APIs and placebo. The study aims to recruit at least 560 patients and will be conducted across multiple sites in the United States and Europe. This follows a successful Phase 2 proof-of-concept study where IHL-42X showed a significant reduction in the apnea hypopnea index (AHI) and was well tolerated. Incannex is addressing the unmet need for pharmacotherapy in OSA treatment, as the current standard of care, Positive Airway Pressure (PAP) machines, has low patient compliance. The global market for OSA treatment is substantial, with an estimated annual economic burden of undiagnosed sleep apnea in the U.S. alone at approximately $149.6 billion.

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