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https://www.incannex.com.au/investors/
https://company-announcements.afr.com/asx/ihl/10ce0ce2-9ffb-11ec-8d2b-62a0ebf3375e.pdf
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Date: March 10, 2022
Public Announcement (NASDAQ: IXHL) (ASX: IHL)
Incannex Healthcare Limited (ABN: 93 096 635 246)
Level 39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
P: +61 409 840 786
Page 1 | 4
Incannex observes substantial reduction in AHI in preliminary results of
clinical trial assessing IHL-42X in patients with OSA; proceeds to
pivotal studies
Highlights:
• 20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to
91.5%) during at least one treatment compared to baseline
• 60% of trial participants experienced a reduction in AHI of greater than 50% (range: 55.0% to
91.5%) during at least one treatment compared to baseline
• Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared
to baseline
• IHL-42X was observed to be well tolerated in the clinical trial
• IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality,
multiple major health benefits and increased quality of life
• The Company has been granted a pre-IND meeting with FDA on May 11, 2022 (U.S. EST)
• Planning commences for pivotal clinical trials to commence after opening an IND with FDA.
Melbourne, Australia, March 10, 2022 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL),
(‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal
cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today
announced the completion of a preliminary analysis of data from its phase 2, proof-of-concept clinical
trial investigating novel cannabinoid combination product, IHL-42X, for the treatment of 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 in patients who suffered from
the disease. Trial participants received each of the three doses of IHL-42X and placebo across four sevenday treatment periods, separated by one week washout periods. At the end of each treatment period,
they attended the clinic for an overnight sleep study where AHI was determined, along with other
measures of sleep quality, quality of life and drug safety. The study was conducted at the University of
Western Australia Centre for Sleep Science and The Alfred Hospital.
A total of eleven participants were recruited to the study and ten participants completed treatment
periods. The crossover design of the study permitted Incannex to generate high quality data with a
reduced participant number compared to a conventional parallel arm study. Each participant serves as
their own internal control and inter-participant variation is eliminated. The study included ten placebo
treatment periods and twenty-six IHL-42X treatment periods totalling thirty-six AHI data points that
were compared to baseline.
Date: March 10, 2022
Public Announcement (NASDAQ: IXHL) (ASX: IHL)
Incannex Healthcare Limited (ABN: 93 096 635 246)
Level 39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
P: +61 409 840 786
Page 2 | 4
Incannex has undertaken preliminary analysis of the study data comparing the AHI during treatment
with IHL-42X across all three dose levels or placebo to baseline. At baseline, the average AHI was 42.84.
For all IHL-42X treatment periods (using low, mid, and high doses), the average AHI was 23.81, a 44.4 %
reduction (p-value 0.0067) compared to baseline AHI. During placebo treatment periods, the average
AHI was 40.08, a 6.4 % reduction (p-value 0.75) compared to baseline. 60% of participants experienced
a reduction in AHI of greater than 50% (range: 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 greater than 80% (range: 82.7% to 91.5%) relative to baseline during at least one
treatment period of one dose strength of IHL-42X.
Specific data from the study, including which IHL-42X doses were received by which patient and when,
remain blinded. Patient response to specific IHL-42X doses (low, mid, and high) and the secondary
endpoints continue to be analysed by contract research organisation, Novotech, and will only be
released to Incannex upon the completion of the analysis as per usual clinical trial processes. This will
include a comparison between IHL-42X doses for each patient, which increases the power of the
analysis, and provides a more robust differentiation of dose strengths. The full clinical study report is
anticipated in Q2 2022.
Preliminary analysis also revealed that IHL-42X was observed to be well tolerated in the clinical trial. All
treatment associated adverse events were consistent with what has been reported for constituent
components of IHL-42X in historic studies.
Chief Scientific Officer of Incannex Healthcare, Dr. Mark Bleackley, said; “We are delighted that IHL42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data
from the proof-of-concept trial. The average reduction in AHI calculated across low, mid, and high-dose
IHL-42X has met our expectations for what would constitute a valuable product for the treatment of
obstructive sleep apnoea. IHL-42X has the potential to reduce disease severity, resulting in improved
sleep quality, multiple major health benefits and increased quality of life. We look forward to the further
analysis of the study data by Novotech, which will include identification of which dose strength
performed best.”
As announced on December 20, 2021, Incannex is preparing for a pre-IND meeting with the U.S. Food
and Drug Administration (‘FDA’) on the future development plan for IHL-42X. The Company and its
medical and scientific advisors have been granted a meeting via teleconference on May 11, 2022 (U.S.
EST). This meeting will provide guidance on what data is required to open an Investigational New Drug
(IND) application with FDA for IHL-42X for treatment of OSA and the design of a larger pivotal phase 2
clinical trial with trial sites in the United States.
Bonus Entitlement Offer
The Board of Directors has progressed its initiative to offer a bonus option entitlement to both reward
shareholders and provide additional funding for the Company in the future. The terms of this
entitlement offer will be finalised imminently and announced to ASX.
Date: March 10, 2022
Public Announcement (NASDAQ: IXHL) (ASX: IHL)
Incannex Healthcare Limited (ABN: 93 096 635 246)
Level 39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
P: +61 409 840 786
Page 3 | 4
About Obstructive Sleep Apnoea
OSA is the most common sleep-related breathing disorder, and it causes people to repeatedly stop and
start breathing for elongated intervals during sleep. It is a major public health problem and IHL-42X
represents a significant commercial opportunity for Incannex as there are no approved
pharmacotherapy treatments available to patients at the present time.
OSA is a serious medical condition that increases the risk of numerous health complications1
. Drops in
blood oxygen levels that occur during OSA increase blood pressure and strain the cardiovascular system.
Many people with OSA develop high blood pressure (hypertension), which can increase the risk of heart
disease. The more severe the OSA, the greater the risk of coronary artery disease, heart attacks, heart
failure and strokes.
People with OSA often have severe daytime drowsiness, fatigue, and irritability due to lack of restorative
sleep at night, which are observed causes of workplace accidents. Those diagnosed with OSA are also at
higher risk of memory problems, headaches, mood swings and depression.
The current standard of care is a continuous positive airway pressure (‘CPAP’) machine, however,
patient compliance to CPAP is low due to discomfort and claustrophobia resulting from pressurized air
being pumped into the mouth during sleep. Incannex anticipates greatly improved treatment
compliance and outcomes from a pharmaceutical product, which could be IHL-42X subject to further
clinical assessment and approval from regulators. Regardless of the discomfort caused by CPAP, the
global annual market for OSA detection and treatment using CPAP and other breathing aids is
approximately US$10 billion per annum and growing2
.
OSA is highly prevalent, affecting approximately 30 million adults in the United States alone. It is
estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is
approximately US$149.6 billion per annum. These costs include US$86.9 billion in lost productivity,
US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents3
.
1https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090
2https://www.fortunebusinessinsights.com/industry-reports/sleep-apnea-devices-market-100708
3https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf
This announcement has been approved for release to ASX by the Incannex board of directors.
END
Date: March 10, 2022
Public Announcement (NASDAQ: IXHL) (ASX: IHL)
Incannex Healthcare Limited (ABN: 93 096 635 246)
Level 39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
P: +61 409 840 786
Page 4 | 4
About Incannex Healthcare Limited
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis
pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive
sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis),
rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing
clinical success, is being pursued for each drug and therapy under development. Each indication represents major
global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available
to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction
with its medical and scientific advisory board and partners.
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of
the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the
date they were first issued and were based on current expectations and estimates, as well as the beliefs and
assumptions of management. The forward-looking statements included in this press release represent Incannex's
views as of the date of this press release. Incannex anticipates that subsequent events and developments may
cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking
statements, whether as of a result of new information, future events or otherwise. These forward-looking
statements should not be relied upon as representing Incannex's views as of any date after the date of this press
release.
Contact Information
Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
joel@incannex.com.au
US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
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