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 recruited two highly experienced lead
principal investigators (PIs) for the IND opening Phase 2/3
clinical trial investigating IHL-42X for treatment of obstructive
sleep apnoea (‘OSA’). Dr John D Hudson of FutureSearch Trials of
Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials
Research Inc, Atlanta, Georgia.
Recruiting the lead PIs is a critical step for
the IND opening Phase 2/3 study as Dr Hudson and Dr Rosenberg, and
their associated facilities, will serve as the first clinical trial
sites for submission to the FDA and for ethics approval from
Institutional Review Boards. Site recruitment and selection in the
US and other jurisdictions is an iterative process and Incannex
plans to recruit approximately 45 sites across multiple
jurisdictions for this pivotal trial.
Dr John D Hudson, Principal Investigator
– FutureSearch Trials of Neurology, Austin, Texas
J. Douglas Hudson, MD, is board certified in
Neurology and Sleep Medicine. He serves as the Principal
Investigator for FutureSearch Trials of Neurology, Austin, Texas.
Dr. Hudson has supervised over 300 clinical trials over the past 20
years mostly related to neurological and sleep disorders and has
been a national and international speaker for these disorders.
Dr. Hudson completed his neurology residency at
the University of Iowa and was Austin’s first board certified sleep
specialist. Past activities include founding the Austin
Neurological Clinic and Sleep Medicine Consultants. He held the
position of President of the Texas Neurological Society, with a
Lifetime Achievement Award and President of the Capital Area
American Heart Association.
FutureSearch Trials consists of two clinical
research facilities in Austin and Dallas, Texas which have been in
operation for over 15 years. The Austin site where Dr. Hudson is
the Principal Investigator focuses on clinical research studies for
treatment of neurological, pain and sleep disorders and features an
on-site sleep lab.
Regarding the IHL-42X trial, Dr Hudson said:
“Clinical trials for novel formulations of medication are
newsworthy for any specialty and sleep medicine is no
exception.
Obstructive Sleep Apnea, affecting millions of
people, remains under treated. This is due in part to patients not
being diagnosed, and in part due to poor patient compliance with
current therapeutic modalities.
While unheard of a few years ago, oral
medications to help reduce the cause of OSA, are now undergoing
further investigation. This is more than exciting, it could prove
to be life-changing for many patients.”
Russell Rosenberg, PhD, Director and CEO
- Neurotrials Research Inc, Atlanta, Georgia
Dr. Rosenberg is currently Chief Science Officer
and CEO of NeuroTrials Research in Atlanta, Georgia. Dr. Rosenberg,
a native of St. Louis, obtained his doctorate in clinical and
research psychology from The Ohio State University and received
specialized training in sleep disorders medicine and research at
Rush Presbyterian - St. Luke's Medical Center in Chicago. He has
more than 35 years’ experience in clinical sleep medicine and
research, acting as an investigator in over 300 clinical trials
including 14 in OSA and 211 in other sleep related disorders. He is
a Board-Certified Sleep Specialist and Fellow of the American
Academy of Sleep Medicine. Dr. Rosenberg is former Chair and
spokesperson for the National Sleep Foundation (NSF) and has
appeared frequently on local and national television news shows
including the Today Show, Good Morning America, CNN, and MSNBC.
Neurotrials Research Inc is a clinical research
facility in Atlanta, Georgia that has been in operation for over 25
years. Neurotrials Research is focused on delivery of trials in
neurology/CNS and sleep indications.
Regarding the IHL-42X phase 2/3 clinical trial
Dr Rosenberg said: “Incannex has developed a sound, rational,
scientific protocol to determine the efficacy and safety of IHL-42X
in subjects with obstructive sleep apnea."
"Many sleep apnea patients cannot adhere to
positive airway pressure therapy, use it for an inadequate period
at night or just refuse it. Having a safe, effective
pharmacological option for obstructive sleep apnea will be a
positive addition to the treatment landscape as it will offer those
that struggle to adhere to positive airway pressure therapy an
alternative therapy.”
CEO and Managing Director, Mr Joel Latham said;
“Our Company is delighted to have the endorsement of two leading
esteemed research scientists with the relevant experience to
advance our IHL-42X drug candidate. Their support is testament to
the efficacy of IHL-42X demonstrated in phase 2 proof of concept
studies. The multi-site clinical trial being arranged is a pivotal
trial, meaning that it can be used for the registration of IHL-42X
for regulatory registration and commercial launch, which is an
exciting development for Incannex after much hard work and
dedication from our broad team of contributors.”
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 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
Forward-looking statementsThis
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 LimitedMr
Joel LathamManaging Director and Chief Executive Officer+61 409 840
786joel@incannex.com.au
Investor Relations Contact – United States
Alyssa Factor Edison Group +1 (860) 573
9637 afactor@edisongroup.com
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