Medical cannabis company Impression Healthcare (ASX: IHL) has revealed it has received an independent strategic assessment report on the FDA approval pathway for cannabinoid IHL-42X from US-based Camargo Pharmaceuticals.
Camargo has advised on over 250 successful FDA applications in the past 17 years with Impression declaring that IHL-42 could potentially obtain FDA new drug approval in around 2.5 years – a considerable improvement over the 12 years it typically takes to approve new molecular entities.
In its indicative timeline, Impression will commence its Phase 2b trials late in the second quarter of 2020 with a Phase 2 “factorial” stage in the third and/or fourth quarter of this year.
Next year, IHL-42X is forecast to move into the final Phase 3 round of trials with a possible new drug application given to the FDA in 2022.
Importantly, Impression is not required to complete pre-clinical and Phase 1 clinical trials prior to commencing Phase 2b trials, given the extensive amount of existing clinical information, including safety data, on the primary constituents of IHL-42X.
With clinical trials on the horizon for the next year at a minimum, Impression said it intends to generate unregistered sales of IHL-42X to keep revenues flowing even before possible registration with the FDA. One plausible sales channel is via Australia’s special access scheme and through dispensaries in the US and Canada, the company said.
Impression said that registration will facilitate prescription by all doctors, physician marketing and access of public reimbursement bodies such as PBS in Australia.
In yesterday’s presentation to the market, Impression explained that IHL-42X addresses an unmet medical need by treating obstructive sleep apnoea – a serious and often life-threatening condition that increases the risk of numerous health complications and affects around 40 million people in the USA alone.
However, according to research, it is believed that only about 10% of people with the condition end up seeking treatment leaving most sufferers undiagnosed and raising the risk of cardiovascular morbidity.
The CPAP Device is currently used as treatment but other research has suggested that patient use of their CPAP is very low due to the cumbersome nature of nosepiece, discomfort and intolerability by spouses.
Currently, there is no pharmaceutical drug treatment approved for obstructive sleep apnoea in any jurisdiction which means IHL-42X is a candidate for several FDA expedited review programs including breakthrough designation, accelerated approval, priority review and fast-tracking approval.
If successful in its attempt to obtain FDA approval, Impression will commercialise its drug within a direct global annual market for obstructive sleep apnoea treatment and detection, valued at close to US$10 billion per annum and growing.