- Participants in Incannex Healthcare’s (IHL) phase two, proof-of-concept clinical study testing a new cannabis combination medication have finished their dosing
- The cannabinoid combination product, IHL-42X, is hoped to treat obstructive sleep apnoea
- The final clinical research report is expected to be delivered in the first quarter of 2022
- In the meantime, IHL is preparing a pre-Investigational New Drug (IND) meeting package with the US FDA scheduled for Q1 2022
- IHL shares are up 3.19 per cent to trade at 48.5 cents
Incannex Healthcare (IHL) has completed the dosing of participants in a phase two, proof-of-concept clinical trial.
IHL is a clinical stage pharmaceutical company developing novel medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs.
The trial is investigating IHL’s novel cannabinoid combination product, IHL-42X, for the treatment of obstructive sleep apnea (OSA).
OSA is the most prevalent sleep-related respiratory problem, and it causes patients to stop and start breathing for extended periods of time during sleep.
The clinical trial compared three doses of IHL-42X to placebo in decreasing the apnoea hypopnea index (AHI), the major diagnostic criterion for OSA.
The research was carried out at The Alfred Hospital and the University of Western Australia Centre for Sleep Science. Participants in the trial were given each of the three dosages of IHL-42X and placebo throughout four seven-day treatment periods separated by one-week washout periods.
At the end of each treatment session, they went to the clinic for an overnight sleep study to assess AHI, as well as other measures of sleep quality, quality of life, and medication safety.
The treatment periods for all participants in the phase two experiment have now been finished, and the data is being examined by Novotech, the contract research firm hired by Incannex to oversee the study and resultant data. The final clinical research report is expected to be delivered in the first quarter of 2022.
Incannex believes IHL-42X provides it with big economic potential because there are currently no authorised pharmacological therapies for OSA.
The company has also begun preparing a pre-Investigational New Drug (IND) meeting package, with the US Food and Drug Administration (FDA) scheduled for Q1 2022.
Managing Director and CEO Joel Latham said the dosing of patients is an “important inflection point for the company”.
“Our preparation for a pre-IND meeting with the FDA demonstrates our commitment to advancing IHL42X into a larger, pivotal phase two clinical trial under an IND application. We expect the pre-IND meeting to occur in the first quarter of 2022,” he said.
IHL shares were up 3.19 per cent to trade at 48.5 cents at 11:09 am AEDT.