Incannex uses December quarter to pursue development of lead drugs for unmet medical needs
Impression Healthcare has commenced the application process to obtain licences from the State Department of Health, Victoria and the Federal Office of Drug Control for the importation, storage, distribution and export of medicinal cannabis products.
Clinical stage pharmaceutical development company Incannex Healthcare (ASX: IHL) has spent the December quarter pursuing the development of its lead drugs and therapies for patients with unmet medical needs.
The company kicked off the period with a completed dosing of participants in its Phase 2a, proof-of-concept clinical trial investigating novel cannabinoid combination product IHL-42X for the treatment of obstructive sleep apnoea (OSA).
Conducted at the University of Western Australia’s Centre for Sleep Science and Victoria’s Alfred Hospital, the trial enrolled OSA patients and assessed the drug’s impact on reducing the apnoea hypopnoea index (AHI) compared to a placebo.
Participants each received three doses of IHL-42X and a placebo across four seven-day treatment periods, separated by one week washout periods, after which they attended a clinic for an overnight sleep study where their AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The trial data is being analysed by contract research organisation Novotech, with delivery of the final report expected during the current quarter in line with Incannex’s listing on the US Nasdaq exchange.
OSA is a serious medical condition affecting approximately 30 million adults in the US alone.
More severe cases carry a greater risk of coronary artery disease, heart attack, heart failure and stroke.
Incannex has filed an international patent application entitled Methods for the treatment of Obstructive Sleep Apnoea as part of its IHL-42X development program.
IHL-675A for lung conditions
During the three months to 31 December, Incannex commenced a Phase 1 clinical trial to assess its multi-use IHL-675A soft gel capsules in healthy volunteers.
Conducted at CMAX Clinical Research in South Australia, the trial aims to demonstrate zero or minimal additional side effects associated with a combined cannabidiol-hydroxychloroquine drug compared to each ingredient alone and that the uptake and metabolism of the two drugs do not materially interfere with each other.
The trial will commence recruiting a total of 36 participants this quarter (evenly divided across three arms) who will each receive one of IHL-675A, cannabidiol or hydroxychloroquine.
Incannex is developing IHL-675A for the prevention and treatment of certain lung conditions (including acute respiratory distress syndrome, chronic obstructive pulmonary disorder, asthma and bronchitis), rheumatoid arthritis and inflammatory bowel disease.
IHL-216A to treat head trauma
Incannex has also been working on IHL-216A which combines CBD with a volatile anaesthetic inhaler agent (isoflurane) for use after head trauma to reduce secondary brain injuries that lead to neurological deficits.
In conjunction with the Department of Neuroscience trauma group at Monash University, the company is conducting an extensive in vivo study on the protective effects of IHL-216A in sports concussion.
The model of traumatic brain injury being used in the study was developed in collaboration with the US National Football League and is a precursor to pivotal in-human trials required for drug registration.
Contract development and manufacturing organisation Vectura Group has continued development of IHL-216A’s inhaled formulation for use in clinical trials following in vivo studies.
Generalised anxiety disorder trial
During the December quarter, IHL also announced that a Phase 2a Psi-GAD clinical trial which combines the administration of psilocybin with specialised therapy to patients with generalised anxiety disorder (GAD) had received approval to proceed from Monash University’s Human Research Ethics Committee.
With 72 participants, the trial will be the largest of its kind in Australia to date.
The study team has commenced the drug importation process, completed the training of trial therapists and finalised trial site infrastructure.
Recruitment for the trial is expected to take place in the current quarter.
Financials
Incannex recorded net cash outflows for the period of $2.96 million while research and development costs of $1.96 million represented the company’s largest expenditure item.
The board of directors confirmed it was contemplating a free bonus option entitlement to reward shareholders; however, no definitive decision has been made on the initiative.
The company is well funded with a cash balance of $19.77 million as at 31 December 2021.