Full Press Release Details
Healthcare June 2023 Quarterly Activities Report and Appendix 4C Cash Flow Statement
Australia, July 28, 2023 - Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL),
( Incannex' or the Company'), is pleased to provide its quarterly activities report and appendix 4C for the
period ended 30 June 2023. Incannex is undertaking a multitude of U.S. Food and Drug Administration ( FDA') research and
development ( R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered
by health professionals.
Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X
the quarter, Incannex received approval from the Bellberry human research ethics committee ( HREC') to commence a bioavailability/bioequivalence
( BA/BE') clinical trial to assess the pharmacokinetics and tolerability of IHL-42X, which is the Company's proprietary
drug for treatment of Obstructive Sleep Apnoea ( OSA').
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.
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.
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.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Submits IND Application to the US FDA for IHL-42X for Obstructive Sleep Apnoea
to the end of the quarter, Incannex successfully submitted an Investigational New Drug ( IND') application to the US Food
and Drug Administration ( FDA') for IHL-42X for treatment of obstructive sleep apnoea. The IND dossier compiled by the Incannex
team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients. It also
includes detailed information on the development, manufacturing, quality and stability of the IHL-42X drug product, as well as the clinical
protocol and investigator information for the Phase 2/3 IND opening clinical trial.
an IND to the FDA is crucial for companies to gain regulatory approval, conduct clinical trials, and engage in scientific dialogue with
FDA whilst they progress investigational drugs through the stages of development in the United States. The FDA review process for an
IND application involves evaluation of the scientific, clinical, and safety aspects to ensure that the proposed clinical trial meets
regulatory requirements. The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multisite
phase 2/3 clinical trial investigating IHL-42X for the treatment of OSA.
engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of OSA
has engaged Fortrea as the contract research organisation ( CRO') to manage the IND opening Phase 2/3 clinical trial investigating
IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are
intolerant, non-compliant, or na ve to continuous positive airway pressure ( CPAP'). This extensive trial will be conducted
across 45 sites, including many in the United States. Fortrea will implement its technology enabled clinical trial solutions designed
to increase drug development efficiency, reduce timelines, and improve compliance.
the time, CEO and Managing Director of Incannex, Mr Joel Latham said, "The initial Phase 2 proof of concept clinical trial over
IHL-42X demonstrated an average reduction in our primary end point, 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%, markedly improved sleep quality and
a reduction in cardiovascular stress. These results were truly remarkable and now allows for this Phase 2/3 trial to be a genuine long-term
safety and efficacy trial. If we again observe such remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident
that our product will be marketable."
are no registered pharmacotherapy (drug) treatments available to people with OSA, representing a major economic opportunity to Incannex
with IHL-42X, should the study achieve its endpoints as in the proof-of-concept trial.
enters a lease for first psychedelic-assisted psychotherapy clinic Melbourne, Australia
the quarter, Incannex subsidiary company, Clarion Clinics Group Pty Ltd, entered a lease for riverfront premises in Abbottsford, Melbourne.
The premises will be used to provide psychedelic-assisted psychotherapy. Fit out and commissioning of these premises is expected to be
complete in August 2023, facilitating the opening of the first clinic shortly thereafter. The clinic is designed as a commercial scale
prototype, which can be scaled up and replicated to other locations. It will have capacity to treat over 600 patients per year in normal
working hours and substantially more in extended hour operations.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
for Incannex's psychedelic clinics business, Mr Peter Widdows said; "The initial clinic is a pioneering venture that will
implement best practice in psychedelic treatment and aims to positively impact the lives of many people suffering with intractable mental
health conditions. It alone is a substantial business opportunity and has the potential to expand into a very sizable venture with the
subsequent planned roll-out of numerous clinics. The estimated Australian market for psychedelic-assisted psychotherapy is anticipated
to be more than $2bn per annum and the global market closer to $60bn. Clarion Clinics Group is uniquely placed to be a significant player
in this market by entering early, having the treatment model, business model and the best qualified people in place."
Announces Final Results from Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of IHL-675A
May, Incannex released the final results from the Phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory
drug IHL-675A. IHL-675A is a combination cannabinoid drug comprising cannabidiol ( CBD') and hydroxychloroquine ( HCQ')
in a fixed dose combination. IHL-675A was observed to outperform either CBD and HCQ in various pre-clinical models of inflammation, including
in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation. Synergistic anti-inflammatory activity of CBD
and HCQ was observed in these distinct pre-clinical studies and was evidence to support the Company's international patent application
Phase 1 trial measured the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the reference listed drugs, Epidiolex
(CBD) and Plaquenil (HCQ). Three cohorts of 12 participants (n = 36) received either IHL-675A, CBD or HCQ and the clinical assessments
were identical across the three arms of the trial. Participants were monitored for adverse events and had blood samples collected for
pharmacokinetic analysis over a four-week period.
is well tolerated in healthy volunteers. Adverse events for IHL-675A were consistent with what was observed, and has been publicly reported,
for Epidiolex and Plaquenil. Both active pharmaceutical ingredients, CBD and HCQ, are absorbed from IHL-675A. Trends in PK profiles indicate
that the uptake of CBD may be more rapid for IHL-675A than Epidiolex and uptake of HCQ may be slower for IHL-675A than Plaquenil. This
could be advantageous for IHL-675A. CBD provides immediate relief for inflammation and pain whereas HCQ is a slower acting molecule and
provides extended relief.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Receives HREC Approval for Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain and Function in Rheumatoid Arthritis
has received approval from the Human Research Ethics Committee ( HREC') for the lead site, Emeritus Research, Camberwell,
VIC for the Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function of IHL-675A in
Patients with Rheumatoid Arthritis.
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.
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.
trial will be managed by Avance Clinical, an Australian and US CRO, who will engage 8-10 clinical trial sites across Australia and New
Zealand, recruiting 128 patients in total. The trial will aim to assess the effect of IHL-675A on pain and function by utilising patient
reported outcomes, disease scores and inflammatory biomarker analysis over a 24-week period. The results of the trial will establish
the safety and efficacy of IHL-675A in rheumatoid arthritis patients and contribute to the combination rule assessment in a 505(b)2 new
drug application dossier with FDA.
Appoints QPS to Advance CannQuit-N (Nicotine), CannQuitO (Opioid) and Renecann Products in the USA and EU
April, Incannex appointed Quest Pharmaceutical Services ( QPS') to provide regulatory advice and manage clinical trials for
the development of CannQuit and ReneCann products for addiction and immune-disordered skin diseases. QPS was founded in
1995 to provide high-quality bioanalytical LC-MS/MS contract services. Since then, QPS has grown from a small molecule bioanalysis shop