IHL is on track to obtain clinical results from its Phase 2b trial in the second half of this year.
Clinical stage cannabinoid and psychedelic medicine company, Incannex Healthcare (ASX:IHL), continues to execute with a run of positive developments across its product development suite of six clinical assets.
This morning, the company flagged two more key updates for IHL-42X, its proprietary formula for the treatment of obstructive sleep apnoea (OSA).
Trial extension
In an important development, IHL confirmed today that it received ethics approval for an open label extension to its ongoing Phase 2b clinical trial.
The open label extension will allow for the recruitment of patients who experienced a benefit from the treatment in the initial trial, for ongoing assessment over an extended timeframe of six months.
The primary end point for the extension is the reduction in Apnoea Hypopnea Index (AHI) “compared to the patient’s original, pre-treatment baseline measurement”, IHL said.
Patient AHI levels will be assessed during three overnight sleep studies at day 28, 64 and 168.
The announcement states that the results of the phase 2b clinical trial will be released in Q4 of 2021 and that Incannex CEO Joel Latham said the company is “delighted” to have received approval for the open label extension study.
“Patients who have finished their dosing regimens in the Phase 2b trial are now eligible to use IHL-42X everyday for an extended period, and the data we gather from this program will be invaluable to our ongoing FDA development plan,” Latham said.
Global patent
In conjunction with its successful application for ethics approval, Incannex advised the market that it has now filed an International Patent Application entitled “Methods for the treatment of obstructive sleep apnoea”.
The filing was made in accordance with the Patent Cooperation Treaty (PCT), which allows IHL to pursue patent protection across its core global markets in North America, the European Union, Japan and Australia.
As part of the application, IHL also carried out an interim analysis on data from its ongoing Phase 2b trial – defined as a double-blind randomised placebo-controlled clinical trial.
Results from that analysis have been included in the application to further support IHL’s claims.
“Importantly, the filing of the patent application secures the filing date of the application and the claims within it,” the company added.
While the interim data was supplied as part of the patent application, patient dosing remains ongoing for some recruits in IHL’s Phase 2b trial at the University of Western Australia’s Centre for Sleep Science.
As a result, the interim results will be kept confidential to ensure the study remains blinded.
“Final results of the trial will be available once all subjects have completed treatment and the Clinical Study Report is finalised, which is anticipated to be in Q4 of 2021,” IHL said.
The updates provided by IHL mark two key developments as it pursues a major global market opportunity with the IHL-42X treatment.
OSA affects around 30 million adults in the US each year alone, and is a core driver of billions of dollars in lost productivity.
In addition, the standard treatment option is the continuous positive air pressure (CPAP) device,, which often causes discomfort for the user and as such has a notoriously low compliance rate.
The successful development of a pharmacological (drug) treatment has the capacity to unlock multi-billion dollar revenue opportunities in the years ahead.
This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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