Clinical stage pharmaceutical development company, Incannex
Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is
pleased to provide quarterly activities update and for the quarter
ended 31 March 2024.
Incannex is undertaking various U.S. Food and
Drug Administration (‘FDA’) research and development (‘R&D’)
programs for cannabinoid pharmaceutical products and psychedelic
medicine therapies. The nearest-to-market projects in the Company’s
therapeutic pipeline are:
- IHL-42X drug
candidate for Obstructive Sleep Apnea (‘OSA’) - Phase 2/3
studies underway.
- IHL-675A drug
candidate for Rheumatoid Arthritis (‘RA’) - Phase 2b
studies also underway.
- Psi-GAD psilocybin
treatment protocol for generalised anxiety disorder: Phase
2b studies commencing following successful Phase 2 proof of concept
studies in 73 patients.
- Clarion Clinics -
opens first clinic for the provision of psychedelic-assisted
psychotherapies in regulatory permissible locations.
IHL-42X for Treatment of Obstructive
Sleep Apnea
IHL-42X is Incannex’s proprietary fixed dose
combination drug comprising dronabinol and acetazolamide for
treatment of OSA, a condition in which a person’s airways are
obstructed during sleep. That obstruction results in reduced oxygen
uptake, poor-quality sleep and higher risk of heart disease, mental
health disorders and accidents due to sleepiness or cognitive
impairment. The current standard of care for OSA are positive
airway pressure (‘PAP’) devices, however, patient compliance with
PAP machines is limited due to patient discomfort. There are no
approved drugs for OSA and IHL-42X is designed to fill this unmet
need, particularly for patients who are intolerant to PAP
machines.
The RePOSA Phase 2/3 Clinical
Trial
The FDA provided clearance for the multi-site
Phase 2/3 IND opening clinical trial in 2023. The trial, which has
been given the name RePOSA, derived from
Revealing the Efficacy of IHL-42X
use in Patients with OSA, will
assess the safety and efficacy of IHL-42X compared to the component
active pharmaceutical ingredients, dronabinol and acetazolamide, as
well as placebo.
Design of the RePOSA study consists of a Phase 2
dose ranging study that will be conducted at twenty-five sites in
the United States. Patients in the Phase 2 study will receive one
of two doses of IHL-42X or placebo for 4 weeks. After 4 weeks
treatment, the patients will undergo assessment using overnight
polysomnography to determine the severity of their sleep apnea, as
well as various patient-reported outcomes and blood sample
collection to determine the effects of IHL-42X on their sleep
quality and the safety of IHL-42X.
The Phase 3 component of the study will expand
the trial to sites in Europe, extend the treatment period to 1
year, and will compare IHL-42X at the optimal dose from Phase 2 to
the component active pharmaceutical ingredients, dronabinol and
acetazolamide, as well as placebo. The study is registered on
clinicaltrials.gov with NCT number NCT06146101.
During the quarter, Incannex focused on
preparing for patient dosing in Phase 2 and achieved the
following:
- All 25 US based Phase 2 trial sites
(‘sites’) have been selected for the RePOSA study. The sites are at
various stages of start-up, as follows:
- Contracts executed with 20
sites.
- 16 sites have full Institutional
Review Board (‘IRB’) approval.
- 11 investigators have been added to
the FDA IND.
- The IHL-42X drug product has been
manufactured and shipped to a depot in the US, from where it will
be distributed to sites. Arrival of drug product at sites will be
followed shortly by commencement of patient dosing.
Preparation for the Phase 3 component of the
trial is being undertaken in parallel with start-up activities for
Phase 2. The 25 US sites selected for the Phase 2 component of the
trial will also participate in Phase 3. The Phase 2 and Phase 3
components are contained within a single protocol that has already
been approved by the IRB. The Phase 3 trial will also include sites
in Germany, Spain, Finland, and the UK. Progress towards Phase 3 in
the quarter included:
- All 30 additional sites have been
selected for Phase 3. This consists of 16 sites in Germany, 7 in
Spain, 2 in Finland and 5 in the United Kingdom (‘UK’).
- EU-CTR package for approval to
conduct the study in Europe is nearing finalisation and
submission.
President and CEO Incannex Inc., Mr Joel Latham
said, “There are no FDA or EMA registered drugs for the treatment
of sleep apnea, which we believe represents a major opportunity for
Incannex to provide patients with a novel treatment option with no
direct market competitors.”
“The initial Phase 2 proof of concept clinical
trial investigating IHL-42X in patients with OSA demonstrated an
average reduction in AHI of 50.7%, with 25% of subjects having a
reduced AHI of >80%. Importantly, we also observed a reduction
in average patient oxygen desaturation index of 59.7% and markedly
improved patient reported sleep quality.”
These results were truly remarkable and has
facilitated our investment in the Phase 2/3 trial. If we again
observe such notable drug efficacy, safely administered over the 52
weeks of the Phase 3 component of the trial, Incannex is confident
that our product will be marketable.”
The IHL-42X
Bioavailability/Bioequivalence Study
Incannex intends to submit a New Drug
Application (‘NDA’) for IHL-42X fixed dose combination drug to the
FDA using the 505(b)2 pathway. The 505(b)2 NDA permits an applicant
to rely on information on the component drug substances, via
previous approved reference listed drugs, from studies not
conducted by Incannex. The previously FDA-approved reference drugs,
dronabinol and acetazolamide, correspond to the active
pharmaceutical ingredients in IHL-42X.
To use the FDA505(b)2 pathway, the
pharmacokinetics of the active pharmaceutical ingredients in
IHL-42X must compared directly to the reference listed drugs. The
Bioavailability/Bioequivalence (‘BA/BE’) study is being undertaken
to assess the bioavailability of IHL-42X and determine the
bioequivalence to the reference listed drugs.
The BA/BE study is progressing and aims to
recruit at least 116 healthy volunteers who will each receive a
single dose of IHL-42X, dronabinol and acetazolamide under fasted
conditions, as well as IHL-42X under fed conditions. After each
drug is administered, patients will have blood samples collected at
defined timepoints over 48 hours. These blood samples will be
analysed for dronabinol, acetazolamide and their relevant
metabolites. This data will be used to determine pharmacokinetic
parameters for the drugs and their metabolites. Participants will
also be monitored throughout the study to collect additional data
on the safety of IHL-42X. The study is registered on
clinicaltrials.gov with NCT number NCT05857384.
Patient recruitment continued during the
quarter, a total of 72 participants have been randomised and
received a minimum of one dose in the trial. No serious adverse
events have occurred to date. An additional site has been added to
hasten the study and screening has commenced at the second
site.
IHL-675A for Treatment of Inflammatory
Diseases
IHL-675A is Incannex’s proprietary fixed dose
combination drug for the treatment of chronic inflammatory
diseases. Inflammatory conditions occur when the body’s immune
system attacks its own tissues and organs causing inflammation,
pain, discomfort, and damage to the affected tissues. IHL-675A is a
multi-use, anti-inflammatory drug targeting rheumatoid arthritis,
inflammatory bowel disease (colitis and Crohn’s disease) and lung
inflammation (COPD, asthma, bronchitis, and ARDS). IHL-675A is a
combination of hydroxychloroquine (‘HCQ’), a registered
pharmaceutical, and cannabidiol (‘CBD’), for which Incannex has
observed synergistic anti-inflammatory activity in pre-clinical
studies.
Incannex’s current focus is on developing
IHL-675A for treatment of rheumatoid arthritis (‘RA’), an
inflammatory condition that predominantly affects the joints.
Although there are various approved treatments for RA, these often
have limited efficacy or come with safety concerns, resulting in
many RA patients continuing to experience pain, which reduces their
quality of life. HCQ is commonly prescribed to patients with RA.
IHL-675A is designed to provide additional therapeutic activity
through the addition of CBD and the synergistic activity with HCQ,
providing relief to patients with pain associated with their
RA.
Phase 2 clinical trial investigating
IHL-675A in patients with Rheumatoid Arthritis
This Phase 2 clinical trial will include a
minimum of 128 participants with RA who are experiencing pain and
reduced function resulting from their disease, regardless of
current treatment status. Participants are randomized to one of 4
arms: either IHL-675A, CBD alone, HCQ alone or placebo. The primary
endpoint for the trial is pain and function relative to baseline,
determined via the score on the RAPID3 assessment at 24 weeks.
Participants 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 (PRO) device. 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 study is
registered on clinicaltrials.gov with NCT number NCT05942911.
Patient dosing commenced during the quarter.
Other progress in the trial has included:
- Site initiation completed at all
ten trial sites
- Screening ongoing
- No serious adverse events reported
to date.
PsiGAD for Treatment of Generalised
Anxiety Disorder
PsiGAD is Incannex’s psilocybin associated
psychotherapy treatment for generalised anxiety disorder (‘GAD’).
GAD is a relatively common, but serious psychiatric condition
affecting around 4-6% of the population during their lifetime. GAD
can severely affect quality of life and professional career
prospects. International guidelines for GAD treatment recommend
selective serotonin reuptake inhibitors (‘SSRIs’), serotonin and
noradrenaline reuptake inhibitors (‘SNRIs’), and pregabalin as
first-line options, with benzodiazepines such as diazepam as
second-line options. GAD is also treated with psychotherapy alone,
or in combination with pharmacotherapies. However, these
traditional treatments show limited efficacy, with less than half
of patients achieving remission following these treatments and
substantial treatment side-effects and cost.
PsiGAD1 – Results from Phase 2A Proof of
Concept Clinical Trial
During the quarter, Incannex released top line
results from the PsiGAD1 clinical trial conducted at Monash
University, based in Melbourne, Australia. The reduction in
Hamilton Anxiety Ratings Scale (‘HAM-A’) score from baseline in the
psilocybin group was 12.8 points, from 29.5 at baseline, to 16.8 at
week 11 (6 weeks following the final dosing session). This
reduction in HAM-A score observed in the psilocybin group was 9.2
points greater than the reduction observed in the placebo group
(-12.8 psilocybin vs. -3.6 placebo; p<0.0001).
Further analysis revealed that 44% of patients
in the psilocybin group were observed to have a clinically
meaningful improvement of at least 50% reduction in anxiety score
from baseline; a ‘response rate’ more than four times higher than
that of the placebo group. 27% of patients in the psilocybin group
achieved full disease remission; a rate five times higher than that
of psychotherapy with placebo. Psilocybin within the context of
PsiGAD psychotherapy was observed to be well-tolerated, with only
mild and moderate adverse events (AEs) reported. The reported AEs
were consistent with the known effects of the drug. No serious or
severe adverse events were observed.
PsiGAD2 IND-opening Phase 2B Clinical
Trial
Incannex subsidiary, called Psychennex,
commenced preparing an FDA Investigational New Drug (‘IND’)
application for the PsiGAD program. The results of the PsiGAD1
study are being incorporated into the IND dossier along with
finalization of the other modules in preparation for submission to
the FDA. Work on the IND dossier during the quarter includes:
- Description of the formulation
development of Incannex’s psilocybin drug product PSX-001 along
with relevant quality and stability data.
- Summaries of clinical and
non-clinical data on the safety and efficacy of psilocybin for the
treatment of GAD.
- Finalisation of the clinical trial
protocol and other study documents with Clerkenwell Health, a UK
based contract research organization specializing in psychiatry and
central nervous system treatments.
The IND opening clinical trial will be conducted
at sites in the US and the UK. In parallel with the preparation of
the IND dossier, Incannex and Psychennex have been working with
Clerkenwell to prepare the corresponding submission to the
Medicines and Healthcare products Regulatory Agency (‘MHRA’), to
allow for conduct of the trial at sites in the UK.
Clarion Clinics
Clarion Clinics has been designed and fitted out
specifically to provide the optimal environment for
psychedelic-assisted therapy. With seven treatments rooms and a
group therapy room, the first operational clinic is a commercial
scale prototype and has the capacity to treat approximately 600
people per year in normal working hours and substantially more in
extended hour operations. Clarion Clinics started to receive its
first patients during the quarter and first revenues from the
operation are expected in the current quarter. Other clinics are
being planned and expected to be larger than the initial
clinic.
Initial response to the clinic opening has been
strong with over 500 potential patients expressing an interest in
treatment to date. Clarion has assembled a world class clinical
leadership team and has the most experienced clinical delivery team
for psychedelic-assisted therapy in Australia. Clarion, per the
Australian Therapeutic Goods Administration (TGA) down-scheduling,
can treat patients with post-traumatic stress disorder (PTSD) and
treatment resistant depression (TRD) by augmenting specialist
psychotherapy with MDMA and psilocybin, respectively.
This announcement has been approved for release to
NASDAQ by the Incannex Board of Directors.
About Incannex Healthcare Inc.
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 NASDAQ as 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 Inc.Mr Joel
LathamChief Executive Officer, President and
Directoradmin@incannex.com.au
Investor Relations Contact – United States
Laine YonkerEdison Group+1 (610) 716
2868lyonker@edisongroup.com
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