Following last week’s deal that saw Impression Healthcare (ASX: IHL) secure the cannabinoid materials it needs to conduct a series of clinical trials, the cannabis company has announced that it has successfully registered its second clinical trial.
Earlier today, Impression confirmed it will investigate the efficacy of its unique IHL-42X medicinal cannabis formulation on obstructive sleep apnoea with secondary outcome measures focused on sleep quality and patient mood.
The IHL-42X cannabinoid formulation for the clinical trial was prepared in full accordance with Australian Good Manufacturing Practice (GMP) standards with import permits “already received” for the key active pharmaceutical ingredients required.
The upcoming trial will be a phase 2a randomised controlled clinical trial designed to investigate the effects of nocturnal IHL-42X on the apnoea hypopnea index (AHI), to be completed by 30 participants over a six-week period.
In addition to examining the effect of IHL-42X on sleep apnoea, the clinical trial will also look at the effect on a total of 36 secondary outcomes including sleep quality.
Furthermore, the trial will also examine the safety of IHL-42X by the number and type of adverse events reported by trial participants.
Currently, Impression is undertaking four clinical trials investigating the use of uniquely formulated medicinal cannabis products for the treatment of obstructive sleep apnoea, traumatic brain injury, concussion, gum disease and temporomandibular joint disorder.
Each indication represents major global markets that are already worth billions of dollars each year as part of the growing sleep device market, with Impression keen to develop viable treatments that can help patients with their symptoms.
Impression’s overarching plan is to continue developing and launch a series of “pharmaceutical-grade” cannabinoid products in Australia, to eventually sell them via Cannvalate, currently Australia’s largest medicinal cannabis distribution network.
To ensure it has maintained the required list of regulatory protocols, Impression registered the completed phase 2a trial protocol on the Australian and New Zealand Clinical Trials Registry (ANZCTR) and now intends to formalise approval for the trial via the Human Research Ethics Committee (HREC).
After all approvals have been obtained, the next step is to carry out patient recruitment and dosing – currently estimated to occur in late September or early October.
Impression said it hopes to prove that the active treatment will reduce AHI, and improve mood and well-being following the completion of the trial, compared to a placebo.
“Obstructive sleep apnoea syndrome is one of the biggest unmet disease burdens in the western world for which there are no current, proven pharmacological treatments,” said Dr Sud Agarwal, non-executive director and chief medical officer of Impression.
“CPAP machines with cumbersome face masks and mandibular splints are the mainstay of treatment currently, but if there was a registered medicine which had the potential to reduce the number of apnoeas suffered, this would be an enormous disruption of the sleep device market,” said Mr Agarwal.