MELBOURNE, Australia, May 17, 2022
/PRNewswire/ -- 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 completed a highly
constructive Pre-Investigational New Drug Application ('pre-IND')
meeting with the U.S. Food and Drug Administration ('FDA') to
discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and
acetazolamide that is being developed as a treatment for
obstructive sleep apnoea ('OSA') in adults. Incannex submitted a
pre-IND meeting package and meeting request to the FDA in
February 2022. The meeting package
included an overview of the development program, and specific
questions Incannex had on the regulatory requirements for opening
an investigational new drug ('IND') application. Opening an IND is
required to conduct clinical trials in the U.S and ensures that
trials are designed so that they meet the data requirements
necessary for FDA marketing approval.
The written responses, and the responses provided in a
teleconference with FDA representatives, were constructive and
supportive, with interest in the project underpinned by the
significant cohort of people diagnosed with OSA and the absence of
pharmacological treatment solutions.
FDA provided guidance on Incannex's proposed long-term
development strategy, including specific parameters to demonstrate
safety and efficacy in phase 2 and 3 pivotal studies. Guidance
provided by the FDA to the Company will inform adjustments to the
clinical trial protocols to ensure that they generate the data
required for a 505(b)(2) new drug application (NDA).
In a decision that will save Incannex time and cost, FDA agreed
that Incannex does not need to conduct studies in animals. In
particular, the agency confirmed that animal toxicology and animal
pharmacokinetic (PK) studies are not required for opening an IND
for IHL-42X. Therefore, the next step for the development of
IHL-42X will be the adjustment of clinical trial designs and
arrangement of operational imperatives necessary to open an IND
with FDA.
Chief Scientific Officer for Incannex, Dr Mark Bleackley, said: "The FDA's interest in
IHL-42X as a potential therapy for OSA was extremely encouraging.
The feedback they provided on the overall proposed development
program was positive. The agency's responses to the specific
questions we posed allow us to revise our clinical trial protocols,
to ensure that we are running highly efficient studies that
generate the type and amount of data the FDA will require in a
future marketing application. The results from the pre-IND meeting
will shape the IHL-42X development program over the coming
months."
Incannex completed a phase 2 proof of concept clinical trial in
2021 to assess IHL-42X in patients with OSA. Preliminary results
from the trial have been published, showing that 60% of trial
participants experienced a reduction in apnea-hypopnea index
('AHI') of greater than 55% during at least one treatment compared
to baseline. 20% of trial participants experienced a reduction in
AHI of greater than 80%. The complete clinical study report is
anticipated to be released in June
2022.
This announcement has been approved for release to ASX by the
Incannex board of directors.
About Incannex Healthcare
Limited
Incannex is a clinical stage pharmaceutical development company
that is developing unique medicinal cannabinoid 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.
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. Incannex is listed on
the Australian Stock Exchange (ASX) with stock code "IHL" and also
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
US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
View original
content:https://www.prnewswire.com/news-releases/incannex-announces-positive-pre-ind-meeting-with-us-fda-for-ihl-42x-for-obstructive-sleep-apnoea-301548749.html
SOURCE Incannex Healthcare Limited