Clinical stage cannabinoid and psychedelic medicine development company Incannex Healthcare (ASX: IHL) has started a phase 1 clinical trial assessing a soft gel capsule formulation of its multi-use drug candidate IHL-675A in healthy volunteers.
The study will be conducted at CMAX Clinical Research in South Australia and managed by Australian contract research organisation Avance Clinical.
It aims to demonstrate that there are zero or minimal additional side effects associated with the combination of cannabidiol (CBD) and hydroxychloroquine (HCQ) as found in IHL-675A, compared to each drug alone.
It will also show that the uptake and metabolism (known as pharmacokinetics) of each drug does not materially interfere with the other.
In addition, Incannex stated that the international patent examiner has labelled IHL-675A patent application “novel and inventive” and meets the requirements for industrial applicability.
The phase 1 trial will recruit 36 patients before year end, evenly divided across three arms with each arm scheduled to receive either IHL-675A, CBD or HCQ.
Safety and pharmacokinetic assessments will be identical across the three arms.
The trial’s results will form part of three US Food and Drug Administration investigational new drug (IND) applications for each of the inflammatory indications being pursued with IHL-675A.
On approval of the IND applications, Incannex plans to conduct further clinical trials partly or wholly in the US.
Pre-clinical studies suggest that IHL-675A has the potential to be a multi-use drug candidate for the prevention and treatment of certain lung conditions (such as acute respiratory distress syndrome, chronic obstructive pulmonary disorder, asthma and bronchitis), rheumatoid arthritis and inflammatory bowel disease.
The treatment options associated with these conditions have a combined global annual market size exceeding $169 billion.
Incannex has previously demonstrated that CBD and HCQ can act synergistically to inhibit production of key cytokines in an in vitro study of human cells and in four distinct in vivo experiments using established models of inflammation.
HCQ is a disease-modifying, anti-rheumatic drug which regulates immune system activity particularly in conditions where the system is overactive.
It can also change the underlying disease process, rather than simply treating the symptoms.
Soft gel capsules
In July, Incannex announced it engaged specialised pharmaceutical manufacturer Procaps SA to produce soft gel capsules for its clinical trial programs.
Procaps’ manufacturing plant has been inspected and approved for good manufacturing practices (GMP) by multiple regulatory agencies including USFDA, Australia’s Therapeutic Goods Administration, Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency.
Incannex said production of the soft gel capsules could ramp up quickly to commercial quantities for sale as an unregistered or registered product in various markets on receipt of positive clinical trial outcomes.