Pet pharmaceuticals company CannPal (ASX: CP1) is in advanced discussions with commercialisation partners for its oral nutraceutical DermaCann, which has demonstrated reduced skin inflammation for dogs with atopic dermatitis.
The company has today announced the completion of its safety and efficacy study for DermaCann - one of three product lines it plans to take to global markets.
CannPal founder and managing director Layton Mills tells Business News Australia the company is well capitalised with just under $2 million in cash, along with expectations of a generous R&D rebate in a few months' time.
"We have come towards the tail end of most of our of most of our more exhaustive research activities that are more costly, so for us now it's an opportunity to really switch on the commercialisation button," says Mills, who won the Health & Fitness category in last year's Sydney Young Entrepreneur Awards.
Treatment with the orally administered medicine DermaCann led to a 51 per cent reduction in Canine Atopic Dermatitis Extent and Severity Index (CADESI-4) scores for dogs over 56 days, compared to a slight increase observed in the placebo group.
Due to the situation with COVID-19 the study size was reduced from 30 to 13, but CannPal highlights the results are clinically relevant given the substantial difference between the placebo and treatment groups.
CannPal still needs to complete a Target Animal Safety study for the product, although Mills describes this as a regulatory study that gives him no concerns about being able to achieve.
"Having said that, we've got enough information and data now generated through the last two or three years to start the authorisation process, under what's called the time shift application," he says.
"CannPal is now in a position where we can start the process of submitting our authorisation dossier for registration of that product in Australia, and then subsequently New Zealand."
In the meantime, there are other markets globally where CannPal can submit existing data on DermaCann without needing to do anything else.
"We can now submit for categories such as herbal supplement authorisations in other regulatory markets, which may be shorter term," he says.
"But there are also markets where we don't need regulatory approval at all such as some states in the US that have implemented legislation that clearly allows for the commercialization of hemp-derived CBD (cannabidiol) products including for animals."
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Other products in CannPal's stable include the patented MicroMAX microencapsulation technology it is taking to the US market through a partnership with the CSIRO.
"We've just commenced a pilot evaluation of that product in the US through the Amazon platform," he says.
"Essentially we will continue that pilot over the next few months to get some feedback from customers, and then look towards expanding on that, whether that's through other geographies or investing further into the US market."
The MicroMax microencapsulation tech from the CSIRO will also be applied as an alternative delivery method for DermaCann in due course.
"We have the ownership of the global rights to that technology for use in animal health, and we certainly do intend on using that technology as a life cycle strategy for the DermaCann product," he says.
"For example the first iteration is in a liquid oral oil formulation. We could certainly apply the technology we've licensed through the CSIRO to formulate that oil into a chew as an additional SKU (stock keeping unit).
"That's also an intellectual property strategy allows you to continue to maintain intellectual property around your product by extending the patent lifetime."
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The group is also in the pilot Phase 2 stage for its lead pharmaceutical drug candidate CPAT-01, meaning it is still "probably some time before commercialisation".
"We've just wrapped up Phase 2A and Phase 2B pilot safety and dose ranging studies, so now that those studies are complete we are waiting on the final data analysis and results of those trials," he says.
"We anticipate using that information to determine how we would continue to build out a study as we move towards getting that product approved by the FDA (US Food and Drug Administration)."Never miss a news update, subscribe here. Follow us on Facebook, LinkedIn, Instagram and Twitter.
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