Incannex Healthcare Inc. · NASDAQ:IXHL
Incannex Healthcare — Technical Presentation (June 2022)
28 slides from Incannex Healthcare's technical presentation, Jun 3, 2022
Slide 1: IHL-42X for treatment of obstructive sleep apnoea Phase II results
IHL - 42X ASX Ticker: IHL | NASDAQ Ticker: IXHL for treatment of obstructive sleep apnoea Phase II proof of concept clinical trial results. 03 June 2022
Slide 2: Disclosure and Disclaimer
Disclosure and Disclaimer Not an offer of Securities This document has been independently prepared by Incannex Healthcare Limited (Incannex) and is provided for informational purposes only . This document does not constitute or contain an offer, invitation, solicitation or recommendation with respec
Slide 3: Company statement on clinical trial results
Company statement Company statement on clinical trial results IHL42x has exceeded our expectations. It has shown substantial clinical benefit to people with obstructive sleep apnoea at the lowest dose given. This not only means people can get the full benefit with a reduced risk of side effects, but
Slide 4: Unmet Medical Need: Obstructive sleep apnoea
Unmet Medical Need Obstructive sleep apnoea (‘OSA’) OSA involves the narrowing of the upper airway during sleep, which interferes with a person’s breathing. Decreased oxygen uptake results in poor - quality sleep. Untreated OSA leads to serious long - term adverse health outcomes including hypertens
Slide 5: Opportunity: IHL-42X Obstructive Sleep Apnea
Opportunity IHL - 42X Obstructive Sleep Apnea Problem OSA leads to serious long term adverse health outcomes but is also grossly undertreated . It is a highly prevalent condition and current treatment options (machines and devices) have poor patient compliance . Solution IHL - 42X has two pharmaceut
Slide 6: Milestones achieved
Milestones achieved Completed proof of concept phase 2 clinical trial – Results indicate that IHL - 42X is effective at reducing AHI in patients with OSA and is well tolerated. – IHL - 42X also reduced oxygen desaturation index, and improved patient reported sleep quality and the number of awakening
Slide 7: Key Observations from Phase II clinical trial
Opportunity Key Observations from phase 2 clinical trial – patients treated and concept confirmed 01. IHL - 42 X in low dose form outperformed medium and high dose with respect to sleep, THC clearance and safety . 02. Low dose IHL - 42X reduced average Apnoea Hypopnea Index (‘AHI’) by an average of
Slide 8: Acetazolamide and dronabinol composition of IHL-42X
– Carbonic anhydrase inhibitor. – Used to treat glaucoma, altitude sickness, epilepsy and other indications. – Increases the difference between prevailing PCO2 and apnoeic PCO2. – Demonstrated as an effective treatment for OSA in 14 clinical studies. – AHI reduction was 23.9 - 27.6% relative to base
Slide 9: Clinical Trial
Clinical Trial Incannex’s proof of concept clinical trial to assess the safety and efficacy of IHL - 42X in patients with OSA. Compared three doses of IHL - 42X to placebo at reducing AHI compared to baseline (primary endpoint). Other assessments included: – Oxygen desaturation index – Plasma THC le
Slide 10: Study Design
Baseline Placebo period IHL - 42X period 1 Results Presentation 10 IHL - 42X period 2 IHL - 42X period 3 Random order of low, medium and high dose IHL - 42X Study Design Observation – Four period cross over study. – Participants had OSA confirmed at baseline, once eligibility was confirmed they comp
Slide 11: Participant demographics
Demographic Results (Mean (Range)) Age 51.82 (39 - 64) Sex (female) 3/11 Childbearing Potential (Yes) 1/11 Race 10 White, 1 Asian Ethnicity Not Hispanic or Latino 100% Height (cm) 178.16 (160 - 187.3) Weight (kg) 92.23 (66.8 - 117) BMI 28.93 (24.9 - 36.9) Education (coded from 1 - 6)* 3.73 (1 - 6) M
Slide 12: IHL-42X reduced AHI at a group level
IHL - 42X reduced AHI at a group level. Results – Low dose IHL - 42X was the most effective dose strength with an average reduction in AHI of 50.7% compared to the baseline. – When comparing the means of the treatment groups, the difference observed for both low and medium dose compared to baseline
Slide 13: IHL-42X reduced AHI when compared within participants
IHL - 42X reduced AHI when compared within participants. Results – 25% of participants experienced greater than 80% reduction in AHI. – All three doses of IHL - 42X led to a statistically significant (p<0.001) reduction in AHI compared to placebo when calculated directly to each participant’s baseli
Slide 14: Summary of AHI data
Baseline Placebo Low Medium Summary of AHI data During IHL - 42X treatment periods AHI was reduced compared to baseline and placebo treatment periods. – This means that when treated with IHL - 42X, the subjects’ breathing was interrupted less frequently during sleep. – This supports Incannex’s hypot
Slide 15: IHL-42X reduced AHI more than monotherapies
IHL - 42X reduced AHI to a greater extent than reported for acetazolomide and dronabinol as monotherapies. Results – IHL - 42X at a low and medium dose reduce AHI to a greater extent relative to baseline than acetazolamide (1) and dronabinol (2) at equivalent doses (based on extrapolation of publish
Slide 16: Summary of comparison with dronabinol and acetazolamide
Baseline Placebo Low Medium Summary of comparison with dronabinol and acetazolamide Low and medium dose IHL - 42X reduced AHI to a greater extent than reported for dronabinol and acetazolamide monotherapies at equivalent doses. – This supports Incannex’s hypothesis that dronabinol and acetazolamide
Slide 17: IHL-42X reduces oxygen desaturation index
IHL - 42X reduces oxygen desaturation index (ODI). Results – IHL - 42X at a low and medium dose led to reduction in ODI of 59.7 and 59.0% respectively. These reductions were statistically significant (p<0.05). Results Presentation 17
Slide 18: Summary of ODI data
Baseline Placebo Low Medium Summary of ODI data Low and medium dose IHL - 42X significantly reduced oxygen desaturation index during sleep. – This means that during low and medium dose IHL - 42X treatment, subjects had more oxygen in their blood – Low oxygen saturation, or high oxygen desaturation,
Slide 19: THC clearance
– THC levels in blood samples collected the morning after dose 7 were below the limit of detection (0.1 ng/mL) in 37.5 % of low dose IHL - 42X samples. 1. https:// www.justice.gc.ca/eng/cj - jp/sidl - rlcfa/qa2 - qr2.html 2. Vindenes, V., et al., (2012) Impairment based legislative limits for drivin
Slide 20: Summary of THC clearance
Baseline Placebo Low Medium Summary of THC clearance Countries that have levels of THC in blood above which driving is prohibited have set limits at 1 - 2 ng/mL. The morning after low dose IHL - 42X 37.5% of subjects had no detectable THC in their blood. In the low dose blood samples that did have d
Slide 21: IHL-42X improved patient reported sleep quality
IHL - 42X improved patient reported sleep quality. Results 1. Schmickl CN,et. al. 2020. Acetazolamide for OSA and central sleep apnea: a comprehensive systematic review and meta - analysis. Chest 158:2632 – 2645. 2. Carley DW,et. al. 2018. Pharmacotherapy of apnea by cannabimimetic enhancement, the
Slide 22: IHL-42X improved sleep metrics captured by actigraphy
Results IHL - 42X improved sleep metrics captured by actigraphy (wearable sleep monitor). During IHL - 42X treatment periods, subjects were asleep for a greater proportion of their time in bed (sleep efficiency) (1) woke up fewer times (2) and were awake for less time (wake after sleep onset (WASO)
Slide 23: Summary of sleep quality
Baseline Placebo Low Medium Summary of sleep quality During IHL - 42X treatment periods subjects reported a higher level of sleep satisfaction than placebo periods. Data from the Actiwatch indicated that subjects were sleeping through the night better than during the placebo period. These data suppo
Slide 24: IHL-42X was well tolerated
IHL - 42X was well tolerated. Results – No serious treatment emergent adverse events (TEAE) were reported during the study. – Low dose IHL - 42X had the lowest proportion of participants reporting TEAEs and the fewest number of total TEAEs compared to other treatment groups. – One participant on hig
Slide 25: Safety summary
Baseline Placebo Low Medium Safety summary IHL - 42X was well tolerated across all three dose levels. Results Presentation 25 – No serious adverse events (side effects) were reported during the study. – The only severe adverse event was reported during the placebo treatment period and was not linked
Slide 26: Conclusions
Results Conclusions 01. Data from phase 2 proof of concept clinical trial supports the potential of IHL - 42X as an effective and well tolerated treatment for OSA, meeting the unmet needs of millions of people. 02. IHL - 42X reduced AHI, improved sleep quality with respect to both patient reported o
Slide 27: Acknowledgments
Acknowledgments Dr Jen Walsh and the team at UWA Centre for Sleep Science for work as a clinical trial site. Prof Terry O’Brien and the team at The Alfred for work as a clinical trial site. Novotech for managing the trial and study data. Agilex for analysis of samples for THC and metabolite levels.
Slide 28: Media, Investor and Partnership Enquiries
Media Enquiries For media related enquiries please contact: Joel Latham joel@incannex.com.au Investor Enquiries For investor related enquiries please contact: Brad Dilkes investors@incannex.com.au Partnership Enquiries For partnership related enquiries please contact: admin@incannex.com.au incannex.
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