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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d)
of the Securities Exchange
Act of 1934
Date of Report January
24, 2024
Incannex
Healthcare Inc.
(Exact name of registrant
as specified in its charter)
| Delaware |
|
001-41106 |
|
93-2403210 |
(State or other
Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
|
Suite
105, 8 Century Circuit Norwest,
NSW 2153
Australia |
|
Not applicable |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s
Telephone Number, including Area Code: +61 409 840 786
(Former Name or Former
Address, if Changed Since Last Report): Not Applicable
Check the appropriate box below if the Form
8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title
of each class |
|
Trading
Symbol |
|
Name
of exchange on which registered |
| Common Stock, $0.0001 par value per share |
|
IXHL |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter)
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
Item 8.01
On January 24, 2024, Incannex Healthcare Inc.
announced that it has commenced dosing in the Phase 2 clinical trial to assess the safety and efficacy of proprietary combination drug
candidate IHL-675A in patients with rheumatoid arthiritis. Further information is included in the press release attached as Exhibit 99.1
hereto, which is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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 hereunto
duly authorized.
| |
Incannex Healthcare Inc. |
| |
|
|
| Date: January 24, 2024 |
|
/s/ Joel Latham |
| |
Name: |
Joel Latham |
| |
Title: |
Chief Executive Officer and President |
Exhibit 99.1
 |
Date:
January 24, 2024 |
| |
Public Announcement (NASDAQ: IXHL) |
Incannex Commences Dosing in Phase 2 Clinical
Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis
MELBOURNE, Australia and NEW YORK, USA, Jan. 24, 2024 (GLOBE
NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical
company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased
to announce that patient dosing has commenced in the Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).
IHL-675A is the Company’s proprietary combination drug candidate
composed of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both of which have well characterized anti-inflammatory activity
when administered individually (1, 2). The primary endpoint of the double-blind, Phase 2 clinical trial is pain and function relative
to baseline determined via the score on the RAPID-3 assessment at 24 weeks. The trial will enroll 128 participants across 10 study sites
in Australia with participants receiving either IHL-675A, CBD, HCQ or placebo. Participants will record their pain and function outcomes
daily, by completing questionnaires on pain, fatigue, joint stiffness, and quality of life, using an electronic Patient Reported Outcomes
device.
Chief Scientific Officer of Incannex, Dr. Mark Bleackley, said; “Commencing
dosing in the Phase 2 clinical trial in patients with RA is an exciting milestone for the development of IHL-675A. Millions of people
are affected by pain associated with rheumatoid arthritis despite the available treatment options. IHL-675A has the potential to address
this unmet need. We look forward to generating data on the safety and efficacy of IHL-675A and sharing this data with FDA and other regulatory
agencies.”
Participants in the Phase 2 trial will attend monthly visits at the
clinical trial site, where blood tests, and physical examinations will monitor additional safety and efficacy outcomes including inflammatory
biomarkers. The trial will also include a sub-study examining joint inflammation and damage via Magnetic Resonance Imaging (MRI). The
results of this trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment
in the FDA505(b)2 new drug application (NDA) dossier.
Background
IHL-675A is a combination drug candidate comprised of hydroxychloroquine
sulfate (HCQ) and cannabidiol (CBD). HCQ is listed as an essential medicine by the World Health Organisation and was developed as an anti-malarial
drug, but its anti-inflammatory activity has led to use in treatment of RA and lupus erythematosus. CBD is approved for use in seizure
disorders but is also commonly used for RA as an unregistered therapy. The established use of the component active pharmaceutical ingredients
to treat RA makes IHL-675A a strong candidate for treatment of RA. IHL-675A is also a potential treatment for other inflammatory conditions
such as inflammatory bowel disease, COPD and asthma.
HCQ acts by interfering with antigen presentation and lysosomal acidification
(2) whereas CBD modulates the activity inflammatory signalling receptors (1). Anti-inflammatory synergy between the two drugs was demonstrated
across a range of preclinical studies and have provided the foundation for a robust intellectual property (IP) position over the IHL-675A
drug candidate.
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
| |
Date:
January 24, 2024 |
| |
Public Announcement (NASDAQ: IXHL) |
A video presentation of IHL-675A for treatment of rheumatoid arthritis
can be found at https://www.incannex.com/clinical-trail/ihl-675a-rheumatoid-arthritis/.
Chronic inflammatory conditions affect tens of millions of people globally.
Rheumatoid arthritis (RA) is estimated to have a global prevalence of 0.46% (3), which equates to approximately 36.8 million people with
RA. Inflammatory bowel disease (IBD) has a global prevalence of 6.8 million (4). Estimated global prevalence of chronic obstructive pulmonary
disease and asthma (COPD) are 391.9 million and 357.4 million respectively (5, 6).
Overview of Results from Phase 1 Clinical Trial Assessing Tolerability,
Safety, and Pharmacokinetics of IHL-675A in Healthy Volunteers
In 2022 and 2023, Incannex undertook a Phase 1 clinical trial to assess
the safety, tolerability, and pharmacokinetics of IHL-675A. The key endpoints of the trial were adverse events and the plasma levels of
the active pharmaceutical ingredients (APIs), CBD and HCQ, and their major metabolites over a 28-day period. IHL-675A was compared to
the reference listed drugs for CBD and HCQ, called Epidiolex and Plaquenil respectively, across all endpoints. The trial included three
cohorts of twelve participants each (total n = 36), with equal evaluations applied across all three groups. Participants were monitored
and had blood samples collected for pharmacokinetic analysis over a 28-day period.
IHL-675A was well tolerated, with no adverse events of concern and
no serious adverse events reported. The same number of treatment related treatment emergent adverse events (TEAEs) were reported for IHL-675A
as for Epidiolex.
Trends in pharma profiles indicate that the uptake of CBD may be more
rapid for IHL-675A than Epidiolex and uptake of HCQ may be slower for IHL-675A than Plaquenil. This could be advantageous for IHL-675A
as a drug product. CBD would theoretically provide accelerated relief for inflammation and pain whereas HCQ is a slower acting molecule
and may provide extended relief.
END
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
| |
Date:
January 24, 2024 |
| |
Public Announcement (NASDAQ: IXHL) |
About Incannex Healthcare Inc.
Incannex is a clinical stage pharmaceutical development
company that is developing unique medicinal cannabinoid 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 20 granted patents and over 30 pending patent applications.
Website: www.incannex.com
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 Inc.
Mr Joel Latham
Chief Executive Officer, President, and Director
admin@incannex.com.au
Investor Relations Contact – United States
Laine Yonker
Edison Group
+1 (610) 716 2868
lyonker@edisongroup.com
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
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Incannex Healthcare (NASDAQ:IXHL)
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