Clinical stage cannabinoid and psychedelic medicine development company, Incannex Healthcare Limited (ASX: IHL) has commenced a phase 1 clinical trial to assess IHL-675A soft gel capsules in healthy volunteers. The study will be conducted at CMAX Clinical Research (CMAX) in South Australia and managed by Australian CRO Avance Clinical.
The aims of the study are to demonstrate that there are no, or minimal, additional side effects associated with the combination of Cannabidiol (CBD) and Hydroxychloroquine (HCQ) compared to each drug alone and that the uptake and metabolism (pharmacokinetics) of the two drugs do not materially interfere with one another.
A total of 36 subjects will participate in the trial, evenly divided across three arms. The three arms of 12 subjects each will receive one of IHL-675A, CBD, or HCQ. The safety and pharmacokinetic assessments will be identical across the three arms of the trial.
IHL-675A comprises a combination of HCQ, a registered pharmaceutical, 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, cannabidiol and hydroxychloroquine, 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 for the prevention and treatment of:
IHL anticipates that the first participants will be recruited in Q4 2021. Subject to clinical success, the results of this clinical trial will form part of three FDA investigational new drug (IND) applications for each of the three indications the Company is pursuing with IHL-675A. Those indications are lung inflammation, rheumatoid arthritis, and inflammatory bowel disease, representing major markets for IHL to pursue with IHL-675A. Once the IND applications are evaluated and approved, the Company intends to conduct phase 2 and 3 clinical trials partly or wholly in the United States.
On the 16th of July 2021, Incannex announced that it engaged Procaps S.A. (‘Procaps’) to manufacture soft gel capsules for the Company’s clinical trial programs. Procaps manufacturing plant has been inspected and approved for good manufacturing practices (GMP) by multiple regulatory agencies including FDA, TGA, Health Canada and MHRA. Production of IHL-675A soft gel capsules can quickly ramp up to commercial quantities for sale as either an unregistered or registered product in various markets upon the achievement of successful clinical trial outcomes.
CMAX Clinical Research
CMAX Clinical Research is an independent clinical research facility, based in Adelaide, Australia. CMAX has been established as a Phase I-II unit since December 1993, making it the longest-running in Australia which has consistently maintained world class standards with a commitment to providing excellence and quality in all areas of clinical service. CMAX has conducted more than 600 studies since the unit was established and was most recently US FDA audited in 2019 with no findings.
CMAX is one of Australia’s most modern Phase I-II clinical facilities, adjacent to Adelaide’s Biomed City. The facility offers 66‐bed capacity for in‐house stays, three sample processing laboratories (including one PC2), secure investigational product storage room and 24‐bed cardiac telemetry system. Features of the modern environment include isolation zones, recreation spaces for participants, purpose‐built monitoring room, secure-swipe access to the facility, and more.
Avance Clinical
Avance Clinical is the largest full-service Australian CRO specializing in delivering quality clinical trials, with globally accepted data, in Australia and New Zealand. Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient, has been providing CRO services in the region for the past 24 years. The company’s clients are biotech companies in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Avance Clinical offers pre-clinical services with their experienced clinic ready team right through to Phases 1 and 2 leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.
With experience across more than 105 indications the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review. Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach.
As a company, Avance Clinical has focused on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of Avance Clinical’s trusted technology partners.
Intellectual Property Considerations
An International Patent Application entitled “Methods and compositions for treating or preventing an inflammatory condition” was recently filed as part of the IHL-675A development program. This application was filed pursuant to the Patent Cooperation Treaty (PCT), thus providing IHL with an opportunity to pursue patent protection in foreign jurisdictions, including key markets (North America, the EU, Japan, Australia, Israel, among others) with established and developing medicinal cannabis industries.