Clinical-stage pharmaceutical company Incannex Healthcare (ASX: IHL) has provided an extensive update in its latest quarterly report.
The company made progress in pre-clinical and clinical trials of three cannabinoid drugs and one psychedelic therapy.
It is also in ‘advanced discussions’ with Monash over another psychedelic drug therapy involving therapeutic virtual reality systems.
In June, Incannex announced positive results from its phase two clinical trial on the effect of cannabinoid IHL-42X to treat patients with obstructive sleep apnoea.
The trial found low dose IHL-42X exhibited “superior safety and efficacy metrics”, was well tolerated, and participants recorded improvements in sleep quality and cardiovascular stress.
The company has sought advice from the US Food and Drug Administration (FDA) on its long-term clinical trial development plan and now intends to arrange the operational imperatives necessary to open an investigational new drug application (IND) with the FDA.
In collaboration with the US National Football League (NFL), Incannex also completed a pre-clinical study comparing its cannabinoid candidate IHL-216A with component drugs cannabidiol (CBD) and isoflurane in a rodent model of sports concussion.
Findings expanded on an initial animal study conducted by Incannex in 2020 and supported the protective effect of IHL-216A in concussion and traumatic brain injury.
The company is now targeting a pre-IND meeting with the FDA in the current third quarter to discuss its intention to conduct an expedited clinical trial program required for regulatory submissions and marketing approval.
Incannex has continued to prepare for a phase one clinical trial to assess its third cannabinoid candidate, IHL-675A soft gel capsules, for multiple inflammatory disorders.
Incannex recently received approval from the Human Research Ethics Committee (HREC) to begin a phase one human clinical trial. Patient recruitment is due to begin next month.
During the June quarter, Incannex continued its phase 2a clinical trial of psilocybin and psychotherapy for generalised anxiety disorder (GAD) with 22 participants currently enrolled and a further eight anticipated to be enrolled during the current September quarter.
Completing dosing of 30 participants in total will pave the way for a mid-assessment of results by an independent statistician.
“Operationally, the trial is proceeding as smoothly as we could have hoped for. We’re currently, undertaking 3 dosage sessions per week, which is one of the fastest rates of recruitment for a clinical psychedelic trial site,” principal investigator of the trial Dr Paul Liknaitzky said.
The company is also in “advanced” stages of discussion with Monash University in relation to a research agreement for clinical trials required to develop a new treatment for severe forms of anxiety disorders that involves combining virtual reality exposure response therapy with a psychedelic drug.
The initial clinical trial will assess efficacy, safety, tolerability and optimal dose of the treatment method.
Corporate activity during the quarter
In May, Incannex completed a binding share sale and purchase agreement to acquire 100% of the issued share capital of APIRx Pharmaceuticals USA, which has 22 active clinical and pre-clinical research and development projects targeting treatment of a range of indications including pain disorders, addiction, mental illnesses, gastrointestinal diseases, among others.
The priority drug candidates are: Medchew Dronabinol for chemotherapy-induced nausea and vomiting; Medchew Rx for pain and spasticity in multiple sclerosis; CanQuit and CanQuitO chewables for nicotine and opioid addiction.
Incannex completed an option program to raise $23.6 million at an exercise price of $0.35 per share during the quarter. At the end of June, the company had $37.5 million in cash at the bank.