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IXHL News
IXHL Events
Incannex Doses First Patient in IHL-42X Study
Incannex announced that the first patient has been dosed in the DReAMzz Phase 2 dose-optimization study of IHL-42X, the company's oral fixed-dose combination drug candidate for the treatment of obstructive sleep apnea. The milestone builds on the positive results from the Phase 2 RePOSA study, in which IHL-42X demonstrated statistically significant reductions in apnea-hypopnea index compared with placebo, with individual reductions in AHI of up to 83% observed and exceptional safety profile.
Incannex Begins Participant Screening for DReAMzz Study
Incannex announced that participant screening has commenced in the company's DReAMzz Phase 2 dose confirmation study evaluating IHL-42X for the treatment of obstructive sleep apnea. IHL-42X has previously been granted Fast Track designation by the FDA, underscoring its potential to address the significant unmet medical need in OSA and providing opportunities for more frequent interactions with the FDA throughout the development process, supporting a potentially expedited pathway towards regulatory review. The first tranche of clinical trial sites have now received approval to commence screening potential participants for the DReAMzz study, marking another important milestone in the advancement of Incannex's lead clinical program towards Phase III development. Additional clinical sites are expected to commence screening activities as they receive the necessary approvals.
Incannex Granted Patent for Obstructive Sleep Apnea Treatment
Incannex announced that the United States Patent and Trademark Office, or USPTO, has granted a patent titled "Compositions and Methods of Treatment for Obstructive Sleep Apnea." The granted patent includes claims directed to the proprietary IHL-42X composition and its associated therapeutic methods for the treatment of Obstructive Sleep Apnea, or OSA. The patent is expected to have a baseline expiry date of July 9, 2040 and the company is exploring its eligibility for patent term extension following potential FDA approval.
Incannex Healthcare Launches DReAMzz Study Evaluating IHL-42X
Incannex Healthcare announced the official commencement of its DReAMzz clinical study evaluating IHL-42X for the treatment of obstructive sleep apnea. The Company has now completed extensive site feasibility assessments, identified all 14 clinical trial sites, completed manufacturing of IHL-42X drug product, secured all required import and export permits, and onboarded its newly appointed global distribution partner in preparation for site activation and patient dosing. The DReAMzz study is designed as a crossover dose optimization study intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase III development program. The study is expected to generate additional data evaluating the relationship between dose optimization, objective sleep metrics, and patient-reported outcomes, which are becoming increasingly important in both regulatory review and commercial positioning within the OSA market. Importantly, the DReAMzz program is designed to further optimize and de-risk the Phase III pathway following the positive Phase II RePOSA clinical trial, where IHL-42X demonstrated statistically significant and clinically meaningful reductions in apnea-hypopnea index, alongside improvements in oxygenation, sleep quality, fatigue-related outcomes and broader patient-reported measures. Incannex believes the DReAMMZ study has the potential to provide the Company with a more efficient pathway toward potential registration by optimizing the Phase III design prior to commencement, while also supporting more disciplined and effective capital deployment.
Incannex Reactivates Share Repurchase Program
Incannex announced that it has reactivated its previously approved share repurchase program, with the program having been active over the past two trading days. The company has utilized the buyback program opportunistically in the past, however had not actively repurchased shares in recent periods. Following its recent financing, Incannex has approximately $75M in cash on hand and no debt.
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