On a path to developing a suite of cannabinoid-based medicines aimed at remedying a range of debilitating conditions, pharmaceutical development company Incannex Healthcare (ASX: IHL) has recruited the first batch of patients for its IHL-42X phase 2b obstructive sleep apnoea (OSA) clinical trial.
The trial will look into how well Incannex’s drug candidate IHL-42X can treat OSA, a highly prevalent condition with limited tolerable treatment options that affects more than 30 million people worldwide.
The condition costs the United States healthcare system more than US$149.6 billion (A$194 billion) every year without an existing approved pharmaceutical treatment available for sufferers.
In Australia, the direct economic cost exceeds A$21 billion per year, according to Deloitte Access Economics.
Following receipt of Human Research and Ethic Committee approval from the Alfred Health Ethics Committee, Incannex plans to conduct a randomised, double-blind, placebo-controlled dose-ranging phase 2b clinical trial to assess the therapeutic benefit of IHL-42X in three different doses. Small Caps first reported on the plans in July this year.
“The entire team at Incannex is excited to have commenced screening for, and formally recruited its first patients to its first-ever in-human trial,” Incannex chief executive officer and managing director Joel Latham said.
Treating sleep apnoea
The prime focus of the impending study is to determine the degree the drug reduces OSA compared to baseline or pre-treatment levels.
Notably, the trial has been classified as a “cross over study”, meaning all participants will receive three doses, plus a placebo. Patients will undergo four treatment periods, each at a different dosage.
Thereafter, the treatment periods will be separated by “washout periods” to allow the drugs to clear from the system, the pharmaceutical company said.
As a further insight into the logistics of the clinical trial, Incannex revealed that on the final night of each treatment period, subjects will visit the sleep clinic at the Alfred Hospital to have their sleep assessed using “overnight polysomnography”, where a measurement of efficacy will be taken in relation to an industry benchmark standard, otherwise known as the Apnoea Hypopnea Index (AHI).
During these clinic visits, surveys will be completed to monitor secondary endpoints with blood samples collected to monitor the safety of Incannex’s drug candidate.
Executing a clinical trial
Incannex’s upcoming trial will be conducted at the Alfred Hospital under the supervision of veteran principal investigator Professor Terry O’Brien.
According to the trial’s stated goals, participants will also be monitored for additional endpoints such as a reduction in the oxygen desaturation index, daytime somnolence, mood and quality of life.
With patients now being onboarded, the pharma company noted epilepsy sufferers could potentially be the most acute beneficiaries from its treatment, given that “obstructive sleep apnoea is more prevalent in patients with epilepsy than the general population and poor sleep quality has been linked to higher seizure frequency”.
Incannex added that Mr O’Brien’s access to patients with comorbid epilepsy and OSA will help progress the clinical trial and allow the company to assess whether an improvement in IHL-42X’s efficacy reduces seizure frequency.
If the trial is successful, Incannex hopes to sell IHL-42X in Australia under the country’s Special Access Scheme alongside its cannabinoid oils and CBD inhaler. Thereafter, the company wants to proceed to a phase two “factorial clinical trial” as it compiles the necessary information for a Food and Drug Administration (FDA) new drug application to achieve market exclusivity in the US.
In a statement to the market, Incannex said if the Alfred trial leads to a “positive result”, the trial will serve as a “major valuation inflection point” for the company.
“Sleep apnoea is a dangerous condition, which has wide-ranging effects on sufferers, and current treatment options are impractical for many,” Mr Latham said.
“A successful pharmaceutical solution would be revolutionary to patients with this condition and we look forward to providing updates on the clinical program as we undertake patient dosing of our unique IHL-42X formulation,” he added.