Incannex Healthcare (ASX: IHL) has released its March quarter (Q3 FY2022) results this week, unveiling significant progress in the company’s psychedelic-based and cannabinoid combination therapeutics over the period.
In February 2022, Incannex began recruiting for a phase 2a psilocybin and psychotherapy trial for treating patients with generalised anxiety disorder (GAD), a project IHL calls “Psi-GAD”.
The first participants for the trial have been enrolled and treatment has commenced. Interestingly, IHL reported that the trial protocol incorporates a range of treatment innovations currently unseen in the field of psychedelic therapy.
Dr Paul Liknaitzky is leading the trial, which was approved by Monash University human research ethics committee back in December.
The trial follows positive feedback from a US Food and Drug Administration (FDA) pre-IND meeting, which Incannex describes was “positive, constructive, and supportive”.
Additionally, the FDA provided guidance over the Company’s long-term development strategy with regards to what is expected for a successful new drug application (NDA) and marketing authorisation.
Virtual reality exposure response therapy and psychedelics
Also during Q3 FY2022, Incannex executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment in combination with a psychedelic drug treatment.
The VR therapy has been established by BrainPark, a state-of-the-art clinical research platform at Monash University’s Turner Institute for Brain and Mental Health.
Incannex will combine the VR ERP therapy tool with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.
Incannex has flagged that it is arranging the research agreement to commence clinical trials at Monash University, again under the guidance of Dr Paul Liknaitzky who both works at Monash and is a member of the Incannex medical advisory board.
As well as advancing psychedelic therapies, Incannex is progressing its novel cannabinoid combination drugs for a range of disorders.
During Q3 FY2022, a phase 2a clinical trial using Incannex’s drug IHL-42X to treat obstructive sleep apnoea resulted in 60% of participants reporting at least a 55% reduction in the apnoea hypopnea index (AHI).
During this trial, 20% of the patients reported a reduction in AHI exceeding 80%.
Meanwhile, an in vivo study on the neuroprotective capabilities of Incannex’s IHL-216A drug was completed during the quarter.
IHL-216A is cannabidiol combined with a volatile anaesthetic agent for administering soon after head trauma with the aim of reducing secondary brain injuries that can lead to neurological deficits.
The Monash Trauma Group at Monash University undertook the in vivo study, which evaluated the protective effect of IHL-216A in concussion and traumatic brain injury.
Results from this study are expected within two-to-three weeks.
Also during Q3 FY2022, Incannex continued preparatory activities for a phase 1 clinical trial assessing its IHL-675A soft gel capsules, which are a combination of cannabinoid and hydroxychloroquine.
This study aims to demonstrate there are no, or minimal, side effects for the drug and the uptake and metabolism of the two drugs do not interfere with each other.
Incannex has completed a pre-IND meeting with the FDA to discuss the regulatory pathway for IHL-675A in treating lung inflammation, rheumatoid arthritis and inflammatory bowel disease.
The company noted the FDA agreed that marketing applications for the drug “should be expedited”.
APIRx Pharmaceuticals acquisition
Another milestone for Incannex during Q3 FY2022 was its announcement to acquire APIRx Pharmaceutical for US$93.3 million in an all scrip deal, set at a price of $0.573 per share.
Incannex describes APIRx as an innovative biotechnology company focused on development of prescription pharmaceutical cannabinoid medicines.
APIRx has 22 active clinical and pre-clinical research and development projects and an “extensive intellectual property portfolio” comprising 19 granted patents and a 23 pending patents.
“The acquisition of APIRx brings to Incannex a diverse portfolio of promising therapeutic candidates targeted at treating an extensive range of conditions, including pain, dementia, Parkinson’s disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, as well as skin and ophthalmic conditions,” Incannex explained.
On the corporate side, Incannex increased its exposure to US investors by listing American Depositary Shares on the NASDAQ global market in February.
The company is continuing to work on boosting its exposure within the North American investment community.
Also during Q3 FY2022, Incannex buoyed its cash reserves to fund ongoing research and development and trials.
The company raised $23.6 million via a loyalty option issue and closed out the quarter with $40 million in the bank.