Impression Healthcare (ASX: IHL) is on the road to gaining a competitive edge in the medicinal cannabis field with four upcoming trials aimed at clinically validating unique cannabinoid (CBD) products for major medical issues.
The disruptive healthcare company only entered the medicinal cannabis space about six months ago and has already made headway with various licence and supply agreements before announcing its latest deal with Australia’s largest network of medical cannabis clinics, Cannvalate.
Under the terms of a binding agreement announced last month, Cannvalate will purchase and distribute Impression Healthcare’s licenced CBD medicines throughout its fast-growing network of more than 1,000 prescribing doctors and 600 pharmacies.
In addition, Cannvalate will fund the majority of the costs to conduct four clinical trials of medical cannabis products.
These include a “first of its kind” trial studying the use of synthetic CBD oil to improve symptoms of traumatic brain injury from sporting incidents.
The other three trials will examine: the use of dronabinol for obstructive sleep apnoea; CBD chewing gum for severe periodontitis, otherwise known as gum disease; and CBD oil for temporomandibular joint disease (TMJ), which is a painful disorder involving restricted movement of the jaw joint and muscles.
Tailor-made products vs a ‘cure-all’
Impression Healthcare chief executive officer Joel Latham spoke with Small Caps about the significant value the clinical trials are expected to unlock for the company.
“What other suppliers are doing is effectively a cure-all product with limited data and limited clinical information backing-up their product, whereas we’ve taken the route to clinically validate everything that we’re doing for those specific issues,” Mr Latham said.
He said having the data clinically proven essentially means Impression Healthcare will be first to market for these indications.
“That’s what doctors want to see within the Australian market – it needs to be clinically proven, clinically validated and we’re going to have all of that behind our products to ensure that its successful once launched and we get it out throughout the Cannvalate network,” Mr Latham added.
In addition, he said creating specific treatments for specific indications allows Impression Healthcare to tailor its marketing towards relevant specialists within Cannvalate’s network of doctors.
“For example, we’d be targeting sleep physicians, dentists or periodontists that specifically look after those issues and our products are specifically related to those professions.”
Current treatment options
These medical cannabis trials as considered some of the first of their kind with the existing available therapies for all four of the conditions being largely inadequate.
Obstructive sleep apnoea
The continuous positive airway pressure (CPAP) machine dominates the market in the treatment of sleep apnoea, but there is currently no pharmaceutical treatment available.
“You wear a mask on your face with a machine that you carry around. It’s extremely intrusive, so we don’t see that as a treatment that patients are going to want to continue with in the future,” he said.
“Additionally, there’s quite a large trial rate with that particular product; however, patients tend to drop off because it does impact their comfortability and essentially their night’s sleep.”
Mr Latham also noted a type of mouthpiece called a mandibular advancement splint, which Impression Healthcare manufactures as part of its dental business.
While these products are less intrusive and do have strong clinical data behind them, he said the company was excited to “open up a completely new market that’s substantial in Australia and across the world” and aims to be the “first in the space”.
Cannvalate chief executive officer and co-founder Dr Sud Agarwal has also described the clinical trials as potentially “game-changing”.
Speaking with Small Caps, Dr Agarwal said periodontitis is a very common condition that usually requires a deep clean at the dentist, which is a highly invasive procedure.
“A CBD pharmaceutical treatment which could be impregnated into toothpaste or mouthwash could create significant changes in community levels of gum disease,” he said.
Dr Agarwal noted that a highly respected senior periodontal specialist Dr Simon Hinckfuss has been enlisted to lead this clinical trial.
Dr Agarwal said TMJ, another common and disabling disease, would often requires very complex physical treatment that would usually include the creation of custom nocturnal mouth splints.
One of Australia’s highest regarded oral medicine specialists, Associate Professor Michael Stubbs, will lead the study into the effects of CBD oil in treating this disease.
Traumatic brain injury
According to Dr Agarwal, traumatic brain injury and sports-related concussion have “no established treatments currently” and is therefore a “massive total addressable market both locally and internationally”.
“If the Impression Healthcare cannabinoid cocktail is proven to be effective, we can see this being used by sportsmen who practise any form of contact sport,” he said.
Product to market timeline
The clinical trials will be conducted at Cannvalate’s medical cannabis research centre, which it operates in conjunction with Melbourne’s Swinburne University.
According to Mr Latham, Impression Healthcare is currently arranging the specifications and physical delivery of products for the trials, which are expected to start within the next six to eight weeks.
“Then from there, it’s a 90-day process and we’re confident that we’re going to have products ready for sale in the second half of this year,” he said.
“Once we’ve been able to prove basic safety and efficacy of our products, then it will be going straight out to the Cannvalate network to begin with, then other distribution channels that we’re forming as well, including our preferred practitioner network of dentists.”
The products will be available via prescription under the Special Access Scheme.
Another part of Impression Healthcare’s agreement with Cannvalate involves the sale and distribution of a “generic” cannabis oil product.
“We’re looking to bring in a generic type of oil that is high CBD-based because that’s a high-sell product within the Australian market at the moment,” Mr Latham said.
“That’s something that we’re finalising, and I look forward to reporting an update on this in a short space of time.”
“With us introducing the medicinal cannabis oils to the products mix, it’s just going to further grow our product portfolio as we continue to add additional products from the conclusion of our clinical trials,” he added.
Melbourne-based Cannvalate operates medical cannabis-prescribing clinics throughout Australia and accounts for 30% of the country’s medical cannabis prescriptions.
Dr Agarwal said his company agreed to fund most of the associated costs of the trials as it is “confident that the outcome will be a great result for the industry and for IHL”.
Impression Healthcare will retain all the intellectual property rights in relation to the clinical trials.
Under the agreement, Cannvalate will be rewarded through various stock options with exercise prices ranging from $0.02 to $0.14 per share, to be vested upon the achievement of milestones associated with the trials.
“We see the value in being a significant shareholder in a company who is advanced in their thinking,” Dr Agarwal said.
He also said Cannvalate will assist Impression Healthcare to undertake “some novel drug discovery for other ailments too, as we firmly believe that cannabinoid-based therapeutics have potential uses in many other diseases”.