The December 2020 quarter heralded Incannex Healthcare’s (ASX: IHL) fifth consecutive period of record sales receipts, while it continued to advance its proprietary therapeutics for sleep apnoea, sepsis associated acute respiratory distress syndrome (SAARDS), traumatic brain injury, and generalised anxiety disorder.
During Q4 2020, Incannex received $735,000 from sales of its cannabinoid products under the Australian Government’s special access scheme.
The company noted this was its fifth consecutive quarter of record sales and it ended the period with $11.8 million in the bank.
As sales of its cannabinoid products continue increasing, Incannex has progressed its proprietary drugs for treating a variety of disorders.
Sleep apnoea clinical trial
During Q4 2020, Incannex began recruiting its first patients for a phase 2b clinical trial.
The trial is evaluating the impact of Incannex’s IHL-42X formulation on obstructive sleep apnoea.
Professor Terry O’Brien is leading the trial which is being held at the Alfred Hospital in Victoria.
Incannex hopes the IHL-42X drug will provide a pharmacological treatment option for the disorder which effects around 30 million people. In the US, obstructive sleep apnoea has an annual economic burden of US$149.6 billion.
SAARDS is one of the nasty and fatal side effects of the COVID-19 and Incannex is advancing its IHL-675A drug as a potential treatment.
During the December quarter, in vitro and in vivo studies confirmed IHL-675a was able to inhibit the key inflammatory cytokines that lead to SAARDS.
The key ingredients in IHL-675A are cannabidiol and hydroxychloroquine.
Incannex is arranging a pre-investigational new drug meeting with the United States Food and Drug Administration to devise the best path forward to begin clinical testing of IHL-675A.
The company will also propose the drug receives emergency use authorisation if a phase 2 clinical trial is successful.
Traumatic brain injury
Another drug Incannex progressed during Q4 2020 was IHL-216A for treating traumatic brain injury.
An extensive in vivo study using IHL-216A found it reduces neuronal damage, neuroinflammation and behavioural deficits that result from traumatic brain injury.
IHL-216A contains cannabidiol and isoflurane which act synergistically. The drug is designed to be administered soon after head trauma to minimise secondary brain injuries that lead to neurological deficits.
Incannex is currently looking at the best clinical trial program for IHL-216A following the success of in vivo research.
Generalised anxiety disorder
Another drug Incannex is keen to advance is psilocybin for treating generalised anxiety disorder.
The company planned a psilocybin-assisted psychotherapy trail during Q4 2020.
At least 72 patients will be recruited for the study which will make it Australia’s largest psychedelic R&D project.
Dr Paul Liknaitzky is heading up the trial and is a known leader in the psychedelic medicine field.
Incannex is calling a pre-IND meeting as soon as possible with the FDA to discuss the trial protocol.