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 July, 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 July 18, 2023, “Fortea to Manage IHL FDA IND Phase2/3 Clinical
Trial”, 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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Date: July 18, 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/1873875/000121390023057570/ex99-1_001.jpg) |
Date:
July 18, 2023 |
|
Public
Announcement (NASDAQ: IXHL) (ASX: IHL) |
Incannex
engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea
Highlights:
| ● | Incannex
has engaged Fortrea as the contract research organisation (‘CRO’) to manage the
IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. |
| ● | The
Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA
who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP’). |
| ● | The
extensive trial will be conducted across 45 sites, including many in the United States. |
| ● | Fortrea
will implement its technology enabled clinical trial solutions designed to increase drug
development efficiency, reduce timelines, and improve compliance. |
| ● | There
are no registered pharmacotherapy (drug) treatments available to people with OSA, representing
a major economic opportunity to Incannex with IHL-42X, should the study achieve its endpoints
as in the proof of concept trial. |
Melbourne,
Australia, July 18, 2023 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’)
a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies
for unmet medical needs, is pleased to announce that it has engaged Fortrea (Nasdaq: FTRE) as the contract research organisation (‘CRO’)
for management of the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA.
The
Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X at the best performing two doses from the proof-of-concept clinical
trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period.
Participants will receive one of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the study. 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’ Apopnea Hypopnea Index score (‘AHI’). All drug treatments will be compared to placebo.
Incannex Healthcare Limited (ABN: 93
096 635 246)
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
P: +61 409 840 786
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023057570/ex99-1_001.jpg) |
Date:
July 18, 2023 |
|
Public
Announcement (NASDAQ: IXHL) (ASX: IHL) |
Fortrea,
formerly Labcorp Drug Development’s Clinical Development and Commercialization Services, was previously engaged to conduct a 12-week
operational feasibility study where the trial design was provided to potential investigators along with a survey to gauge interest in
conducting the study and identify any region-specific regulatory hurdles. This study involved contacting 195 potential trial sites across
14 countries in North America, Europe, South America, and Australasia. Sixty-three sites expressed interest in participating in the IHL-42X
study. Incannex is targeting 45 clinical trial sites to be included in the study and recently appointed two highly experienced lead principal
investigators to the study.
Fortrea
will use its high-value data sets, combined with its technology enabled clinical trial solutions to improve study recruitment, reduce
study risk, safeguard data quality, and gain operational insights as the trial progresses.
CEO
and Managing Director of Incannex, Mr Joel Latham said, “The initial Phase 2 proof of concept clinical trial over IHL-42X demonstrated
an average reduction in our primary end point, AHI of 50.7%, with 25% of subjects having a reduced AHI of >80%. Importantly, we also
observed a reduction in average patient oxygen desaturation index of 59.7%, markedly improved sleep quality and a reduction in cardiovascular
stress. These results were truly remarkable and now allows for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial.
If we again observe such remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident that our product will
be marketable.”
“Fortrea
has been a valuable partner to Incannex for a long time over multiple projects and we have full confidence that its team will successfully
manage this very important trial. Fortrea’s familiarity with the study and established relationships with potential trial sites
will expedite the study start up and site engagement activities.”
This
announcement has been approved for release to ASX by the Incannex Board of Directors.
END
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 published 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
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.
Incannex Healthcare Limited (ABN: 93
096 635 246)
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
P: +61 409 840 786
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023057570/ex99-1_001.jpg) |
Date:
July 18, 2023 |
|
Public
Announcement (NASDAQ: IXHL) (ASX: IHL) |
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
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
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
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 19 granted patents and 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
Incannex Healthcare Limited (ABN: 93
096 635 246)
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
P: +61 409 840 786
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390023057570/ex99-1_001.jpg) |
Date:
July 18, 2023 |
|
Public
Announcement (NASDAQ: IXHL) (ASX: IHL) |
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
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