Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company’s Proprietary Drug for Treatment of Obstructive Sleep Apnoea (‘OSA’)
06 7월 2023 - 9:42PM
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 Incannex has received approval from Bellberry
Human Research Ethics Committee to commence a
bioavailability/bioequivalence (‘BA/BE’) clinical trial on IHL-42X,
the Company’s proprietary drug product for treatment of obstructive
sleep apnoea.
The BA/BE clinical trial will assess the
pharmacokinetics and tolerability of the two active pharmaceutical
ingredients (‘APIs’) in IHL-42X, dronabinol (‘THC’) and
acetazolamide, compared to the respective FDA reference listed
drugs, as well as the effect of food on pharmacokinetics of the two
APIs.
The study will include 116 participants who will
each complete four (4) single dose treatment periods, being dosed
with IHL-42X, dronabinol and acetazolamide under fasted conditions
as well as IHL-42X under fed conditions. Blood samples will be
collected over 48 hours and the concentrations of the APIs and
their major metabolites in the samples will be analysed.
The clinical trial will be conducted at CMAX
Clinical Research in Adelaide, South Australia and managed by
Novotech. The design of the BA/BE trial is consistent with US Food
and Drug Administration (‘FDA’) recommendations and specific advice
received by Incannex in its pre-IND with the FDA regarding the
development of IHL-42X for treatment of OSA.
The results of the BA/BE trial will form a
critical component of a future new drug application (‘NDA’),
providing the necessary bridge to the reference listed drugs,
thereby facilitating the use of historic safety data via the
FDA505(b)2 regulatory pathway. Importantly, the BA/BE study will
run in parallel to the pivotal Phase 2/3 trial that will commence
after the Company opens an IND with the FDA.
Incannex Chief Scientific Officer Dr Mark
Bleackley said: “The BA/BE trial is a very important component of
the IHL-42X pipeline. Being able to bridge to historic safety data
on the reference listed drugs for dronabinol and acetazolamide
accelerates the development of the drug product and reduces cost
and timelines. Approval of the study by Bellberry HREC for the
BA/BE study allows us to move towards patient recruitment and data
collection with CMAX and Novotech.”
This announcement has been approved for
release to ASX by the Incannex Board of Directors.
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.
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.
References1https://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
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
9637afactor@edisongroup.com
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