Incannex Healthcare has completed dosing of participants in a phase II, proof-of-concept clinical trial investigating its novel cannabinoid combination product IHL-42X for the treatment of obstructive sleep apnoea (OSA).
The company has also started preparing a pre-investigational new drug (IND) meeting package and is targeting a pre-IND meeting with the US Food and Drug Administration (FDA) early next year.
The clinical trial, at the University of Western Australia Centre for Sleep Science and the Alfred Hospital, assessed three doses of IHL-42X at reducing the apnoea hypopnoea index, the main diagnostic criteria for OSA, compared to placebo in patients who suffered from the disease.
All participants have now completed treatment and the data is being analysed by contract research organisation Novotech, with results expected in Q1 2022.
Managing director and CEO Joel Latham said: “OSA remains a significantly unmet medical need and can lead to a variety of cardiovascular complications, with no FDA-approved pharmacotherapies.
“We believe IHL-42X can potentially offer meaningful benefit to this large patient population.”
Meanwhile, the company is targeting an initial public offering and US Nasdaq listing early next year having adequately addressed comments from the US Securities and Exchange Commission. It secured shareholder approval for the move in September.