Cannabinoid and psychedelics biotech Incannex Healthcare (ASX: IHL) has completed dosing of participants in its phase two proof-of-concept clinical trial of IHL-42X for the treatment of obstructive sleep apnoea.
The company has also commenced preparation of a pre-investigational new drug (pre-IND) meeting package, targeting a meeting with the US Food and Drug Administration (FDA) in the 2022 first quarter.
Today’s announcement follows Incannex’s update last week informing shareholders of its expected Nasdaq listing next month.
The phase two trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index (AHI), the main diagnostic criteria for obstructive sleep apnoea, compared to placebo in patients suffering from the disease.
Trial participants at the University of Western Australia Centre for Sleep Science in Perth and the Alfred Hospital in Melbourne received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, the participants attended the clinic for an overnight sleep study where AHI was determined along with measures of sleep quality, quality of life and drug safety.
The data is now being analysed by the contract research organisation Novotech with the final clinical study report anticipated for delivery in the 2022 first quarter.
Incannex chief executive officer and managing director Joel Latham said dosing of the last patient in the phase two trial marked an important inflection point for the company as it continues to advance its pipeline of cannabinoid pharmaceutical products through the clinic.
“We believe that novel cannabinoid combination IHL-42X can potentially offer meaningful benefit to this large patient population [with obstructive sleep apnoea],” he added.
Patent application and pre-IND meeting
Incannex also submitted a patent application regarding the methods for the treatments of obstructive sleep apnoea, based on results of a confidential interim analysis of date from the trial in July.
“The key claims in the application were deemed novel and inventive by the International Search Report and Opinion, thus strengthening our intellectual property around IHL-42X,” Mr Latham said.
The company is also targeting a pre-IND meeting with the FDA in the first quarter of next year.
“Our preparation for a pre-IND meeting with the FDA demonstrates our commitment to advancing IHL-42X into a larger, pivotal phase two clinical trial under an IND application,” Mr Latham said.
At the end of last week, Incannex updated the market on its proposed initial public offering (IPO) in the US.
The company addressed comments from the US Securities and Exchange Commission (SEC) after securing shareholder approval in September and as a result, it now expects its Nasdaq listing to occur next month.
“We are grateful to our team for their work on the registration process and now look forward to marketing the offering and listing on Nasdaq in January, when institutional investors are back on deck after the relatively short winter holiday period in the northern hemisphere,” Mr Latham said.