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 received approval from Bellberry Human
Research Ethics Committee (‘HREC’) for the lead site, Emeritus
Research, Camberwell, Victoria, for its Phase 2 clinical trial. The
trial is pivotal in nature and will assess the efficacy of
IHL-675A, its proprietary anti-inflammatory combination drug
product, in patients with rheumatoid arthritis (‘RA’).
The Phase 2 trial follows the successful Phase 1
clinical trial, results of which were released on 1 May, 2023,
whereby both active pharmaceutical ingredients, cannabidiol (‘CBD’)
and hydroxychloroquine sulphate (‘HCQ’), were absorbed from the
Company’s proprietary fixed dose combination product IHL-675A.
The drug product was also observed to be well
tolerated, with no adverse events of concern. Prior to commencing
clinical trials, Incannex observed positive results from an animal
model of RA. IHL-675A was observed to be more effective at reducing
arthritis across multiple assessments including clinical score, paw
volume, pannus score, total histology score and serum cytokine
levels than the rodent equivalent of the standard dose of HCQ or
equivalent doses of CBD.
The reduction in disease assessments achieved by
IHL-675A was 1.06-3.52 times that observed for HCQ alone at the
standard dose. These promising observations led the company to
prioritise rapid clinical assessment, particularly given that HCQ,
marketed as Plaquenil and generic equivalents, is a common
long-standing treatment prescribed for RA with a considerable
market profile.
The Phase 2 study, that has now been approved by
HREC at the lead site Emeritus Research, Camberwell, Victoria, will
assess the efficacy, safety and tolerability of IHL-675A compared
to the respective component Active Pharmaceutical Ingredients
(APIs), CBD and HCQ, and placebo. The treatments will be double
blinded, meaning neither the investigators nor patients will know
which treatment an individual is receiving.
The study will be managed by Avance Clinical, an
Australian and US CRO (Avance). Recruitment of additional sites
with experience in rheumatology clinical trials is ongoing, with
the goal of 8-10 sites across Australia and New Zealand being
included in the study.
The trial will include 128 participants who meet
the eligibility criteria and is designed to include patients who
have on-going pain and reduced function while on stable treatment
for their RA. Participants will be randomised to one of 4 arms:
either IHL-675A, CBD alone, HCQ alone or placebo. The primary
endpoint for the study is pain and function relative to baseline
determined via the score on the RAPID3 assessment at 24 weeks.
Participants will also 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 (similar to completing a questionnaire on
a smart phone or tablet).
The participants 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 damage via MRI. Subjects will be assessed
for eligibility in the MRI study based on their Rheumatoid
Arthritis Magnetic Resonance Imaging Score (RAMRIS) at
screening.
The results of the trial will establish the
efficacy of IHL-675A in RA and 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.
Incannex Chief Scientific Officer Dr
Mark Bleackley said: “HREC approval for the Phase 2
clinical trial is a key step in the development of IHL-675A for
treatment of pain and reduced function associated with rheumatoid
arthritis. We look forward to working with Emeritus and Avance to
assess the effect of IHL-675A in this patient population.”
About IHL-675A
IHL-675A comprises a combination of HCQ, an
expired patent registered pharmaceutical drug, and CBD. HCQ is a
disease modifying anti-rheumatic drug that regulates the activity
of the immune system, which may be overactive in some conditions.
HCQ can modify the underlying disease process, rather than simply
treating the symptoms. Incannex has demonstrated that IHL-675A
components, CBD and HCQ, act synergistically to inhibit production
of key inflammatory cytokines in an in vitro study of human cells
and in four distinct successful in vivo experiments using
established models of inflammation.
Incannex has evaluated the results of these
experiments and believe IHL-675A to be a multi-use drug candidate
suitable for the prevention and treatment of inflammation, with an
initial focus on: rheumatoid arthritis, inflammatory lung
conditions (acute respiratory distress syndrome, COPD, asthma, and
bronchitis), and inflammatory bowel disease.
A Phase 1 clinical trial assessing the
tolerability and pharmacokinetics has completed patient dosing with
no adverse events of concern reported. The pharmacokinetic data is
currently being analysed.
The treatment of these indications has a
combined global annual market size exceeding US$125B per annum1.
IHL has completed a pre-IND meeting with the FDA to discuss the
regulatory pathway for the development of IHL-675A in the United
States and plan to open INDs for each of the three indications. FDA
agreed that marketing applications for IHL-675A should be 505(b)(2)
applications due to the existence of certain safety and efficacy
information on the active ingredients of IHL-675A originating from
historical studies that we are entitled to use in a new drug
application.
HCQ is approved for treatment of rheumatoid
arthritis and is used by a significant cohort of patients with the
disease. Many patients are also reportedly using non-cGMP grade CBD
to ameliorate their symptoms. The intention of Incannex is to
undertake clinical trials for its proprietary fixed dose
combination of HCQ and CBD to achieve FDA marketing approval for a
pharmaceutical grade IHL-675A product that can be prescribed by a
patient’s doctor.
Emeritus Research
Emeritus Research is a group of private clinical
trials sites that successfully delivers clinical trials in all
therapeutic areas outside of oncology, currently based in
Melbourne, Victoria and Sydney, New South Wales. All Emeritus
Research sites conduct First in Human (FIH) Phase I to Phase IV
trials in their out-patient facilities. With versatile private
sites, Emeritus Research can quickly scale up or down resourcing,
implement new procedures and determine the best approach to
successfully execute clinical trials. Each site within the Emeritus
group is centrally managed to provide continuity between site
quality, start-up, recruitment, and trial conduct.
Avance Clinical
Avance Clinical is the largest premium
full-service Australian and North American CRO delivering quality
clinical trials, with globally accepted data, in Australia, New
Zealand and the US for international biotechs. The company’s
clients are biotechs in their drug development phases that need
fast, agile, and adaptive solution-oriented clinical research
services.
Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan
Asia-Pacific CRO Market Leadership Award recipient for the past
three years, has been providing CRO services in the region for more
than 26 years.
Pre-clinical through to Phase I and
Beyond
Avance Clinical offers pre-clinical consultancy
services with their experienced ClinicReady team right through to
Phase I and beyond clinical services leveraging significant
Government incentive rebates of up to 43.5% and rapid start-up
regulatory processes that are available in Australia.
With experience across more than 110 therapeutic
indications, Avance Clinical can deliver world-class, high-quality,
internationally accepted data suitable for FDA and EMA review.
Technology
Avance Clinical uses state-of-the-art technology
and gold-standard systems across all functional areas to provide
clients with the most effective processes. Medidata, Oracle, Zelta,
Veeva and Medrio are just some of Avance’s technology partners.
This announcement has been approved for
release to ASX by the Incannex Board of Directors.
Reference:
1https://www.alliedmarketresearch.com/rheumatoid-arthritis-RA-drugs-market#:~:text=The%20global%20rheumatoid%20arthritis%20drugs,pain%20and%20inflammation%20in%20jointshttps://www.grandviewresearch.com/industry-analysis/inflammatory-bowel-disease-ibd-treatment-market#:~:text=The%20global%20inflammatory%20bowel%20disease,market%20over%20the%20forecast%20period
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
StatesAlyssa FactorEdison Group+1 (860) 573
9637afactor@edisongroup.com
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