- Medicinal cannabis company Impression Healthcare (IHL) is edging toward U.S. regulatory approval for its obstructive sleep apnoea drug
- The company says the product has been given the green light by an independent reviewer for the 'New Drug Approval' scheme in the states
- Phase 2b clinical trials for the cannabidiol-based drug will kick-off before the end of June
- If all goes according to plan, Impression could have Food and Drug Administration approval in less than three years
- Shares in the company are up just under 14 per cent today and currently worth 3.3 cents each.
Medicinal cannabis company Impression Healthcare (IHL) has U.S. regulatory approval in sight for its obstructive sleep apnoea (OSA) drug candidate.
The company's IHL-42X drug is potentially less than three years away from U.S. Food and Drug Administration (FDA) approval, according to independent reviewer Camargo Pharmaceutical Services.
Camargo, who was commissioned by Impression to outline an FDA pathway for IHL-42X, said the cannabinoid drug is a potential candidate for the "New Drug Approval" scheme in the States, which could cut the time and cost for commercialisation.
What is IHL-42X?
IHL-42x is one of Impression's drug candidates currently in clinical trial. The drug is designed to treat OSA without the hassle of conventional continuous positive airway pressure (CPAP) treatment.
Currently, there is no pharmaceutical treatment for OSA. Sufferers need to wear masks or mouthguards — often attached to machines — to get a good night's sleep.
For IHL-42X, however, Impression claims there is a "substantial body of research" that proves the drug can help stabilise sleep-related respiratory rhythm and reduce the symptoms of sleep apnoea.
Further, the company said Camargo's review of the drug affirmed this research.
Impression has other cannabidiol (CBD)-based products currently in different phases of clinical trials. These include treatments for gum disease, concussion or brain injuries, and temporomandibular joint dysfunction (TMJ).
Impression already has a head-start with its OSA drug because of the primary ingredients in the treatment.
According to the company, IHL-42X can skip pre-clinical and first-phase clinical trials because enough data and clinical information on the core components of the treatment is publically available.
This means Impression plans to kick off Phase 2b clinical trials of the product before the end of June 2020.
If all goes according to plan, Phase 3 will begin in mid-2021, and the company will apply for FDA New Drug Approval in 2022.
This would be a significant turnaround time for Impression. Gaining regulatory approval for drugs like IHL-42X can often take up to 12 years.
In the meantime...
As clinical trials move ahead, Impression plans to start earning cash through IHL-42X as soon as mid-2020.
Once Phase 2b trials have started, the company can start selling the product in Australia through our Special Access Scheme, and from dispensaries in the U.S. and Canada.
The company seems confident there is a strong market for OSA treatment and, subsequently, IHL-42X.
The waiting game
Of course, all of this is entirely dependent on the results from Impression's upcoming clinical trials.
The company has all the framework in place to move forward, and now it is up to management to prove that this drug can do what the company claims it can do.
Impression operates in a modest $23.67 million market cap and it seems investors are happy to wait for trial results before clinching any major buy orders.
Still, Impression shares have gained 13.79 per cent after today's news, reflecting the wider market. At lunchtime AEDT, shares in Impression are trading for 3.3 cents each.