Incannex Healthcare Limited (NASDAQ:IXHL) has completed a preliminary analysis of data from its Phase 2 trial of a cannabinoid combination product, IHL-42X, for obstructive sleep apnoea (OSA).
- The clinical trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index (AHI), the main diagnostic and monitoring criteria for OSA, compared to placebo.
- For all IHL-42X treatment periods (using low, mid, and high doses), the average AHI was 23.81, a 44.4 % reduction from the baseline score of 42.84, compared to a 6.4% reduction in the placebo group.
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- 60% of participants experienced a reduction in AHI of over 50% (55.0% to 91.5%) and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X.
- 20% of participants experienced a reduction in AHI of over 80% (82.7% to 91.5%) relative to baseline.
- Incannex is preparing for a pre-IND meeting with the FDA on the future development plan for IHL-42X, scheduled on May 11.
- The meeting will guide what data is required to open an Investigational New Drug (IND) application for a larger pivotal phase 2 trial.
- Price Action: IXHL shares closed at $10.46 on Tuesday before trading halt.
