UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form 6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
under
the Securities Exchange Act of 1934
For
the month of August, 2023
Commission
File Number: 001-41106
Incannex
Healthcare Limited
(Exact
name of Registrant as specified in its charter)
not
applicable
(Translation
of Registrant’s name into English)
Australia
(Jurisdiction
of incorporation or organization)
Joel
Latham
Chief
Executive Officer and Managing Director
Level
39, Rialto South Tower
525 Collins Street
Melbourne
3000
Australia
(Address
of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F:
Form 20-F ☒
Form 40-F ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
On August 22, 2023, “US
FDA Completes Review of IHL-42x IND Application”, a copy of which announcement is attached to this Form 6-K as Exhibit
99.1.
Signatures
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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Incannex Healthcare Limited |
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|
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Date: August 22, 2023 |
By: |
/s/ Joel Latham |
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Name: |
Joel Latham |
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Title: |
Chief Executive Officer and Managing Director |
INDEX TO EXHIBITS
3
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023069624/ex99-1_001.jpg) |
Date: August 22, 2023
Public Announcement
(NASDAQ: IXHL) (ASX: IHL) |
Review of IND Application for IHL-42X by US
FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed
Melbourne, Australia, August 22, 2023 –
Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical
company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased to
announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct the Company’s Investigational
New Drug (‘IND’) opening pivotal IHL-42X Phase 2/3 clinical trial in the United States as planned.
Incannex submitted the IND application on 20 July
2023 and the FDA completed their review of the substantial application package during the allocated 30-day period. Incannex received communication
that the FDA review was completed, and the IND-opening clinical trial is deemed safe to proceed following assessment of the trial protocol,
lead trial investigators, and a risk benefit analysis of the trial and prospective product. The IND opening trial will assess the effect
of IHL-42X in obstructive sleep apnoea patients who are non-compliant, intolerant, or naïve to positive airway pressure treatment,
such as that administered by CPAP devices.
Incannex will continue the start-up process for
the Phase 2/3 clinical trial. This will include finalisation of institutional review board (IRB) applications and submissions for the
lead clinical trial sites. Site selection, approvals and IRB submission for additional study sites will continue in parallel.
In the IND opening Phase 2/3 clinical trial, participants
will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial. All participants will complete daily
surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures
of safety and efficacy. Every three (3) months, overnight polysomnography will be conducted to determine the effect of treatment on the
patients’ Apnea Hypopnea Index (AHI) along with a range of other sleep parameters. All drug treatments will be compared to placebo.
This announcement has been approved for release
to ASX by the Incannex Board of Directors.
END
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 | 3
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023069624/ex99-1_001.jpg) | Date: August 22, 2023 Public Announcement (NASDAQ: IXHL) (ASX: IHL) |
About IHL-42X
IHL-42X is a synergistic composition of dronabinol,
a synthetic form of tetrahydrocannabinol (THC), and acetazolamide, a carbonic anhydrase inhibitor. Results from a Phase 2 proof of concept
clinical trial undertaken by Incannex were released in 2022. Incannex observed that IHL-42X reduced average apnoea-hypopnoea index (‘AHI’)
by an average of 50.7% versus baseline assessments and 25% of participants experienced greater than an 80% reduction in the AHI. No serious
treatment emergent adverse events were reported during the clinical trial. Furthermore, THC concentrations in blood were below the limits
for impaired driving the morning after nocturnal dose administration of IHL-42X.
About Obstructive Sleep Apnoea (‘OSA’)
OSA is the most common sleep-related breathing
disorder. It involves the narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake,
resulting in poor-quality sleep1. Untreated OSA leads to serious long-term adverse health outcomes including hypertension,
cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk
of accidents. There are no pharmacotherapy (drug) treatments available to those afflicted.
The current ‘standard of care’ is
the Continuous Positive Airway Pressure (‘CPAP’) machine. However, patient compliance to CPAP is low due to various factors
related to patient discomfort. Incannex anticipates greatly improved treatment compliance and outcomes from a pharmaceutical product,
such as 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 aides 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.
References
1 | https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090 |
2 | https://www.fortunebusinessinsights.com/industry-reports/sleep-apnea-devices-market-100708 |
3 | https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf |
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 obstructive
sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis,
inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
U.S. FDA approval and registration, subject to
ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently
has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic
opportunities to Incannex and its shareholders.
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 | 3
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023069624/ex99-1_001.jpg) | Date: August 22, 2023 Public Announcement (NASDAQ: IXHL) (ASX: IHL) |
Incannex 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. The Company
holds 20 granted patents and over 30 pending patent applications. Incannex is listed on the Australian Stock Exchange (ASX) with stock
code “IHL” and has American Depository Shares listed on NASDAQ under code “IXHL”.
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
Investor Relations Contact – United States
Alyssa Factor
Edison Group
+1 (860) 573 9637
afactor@edisongroup.com
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 | 3
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