"Having the data now to actually move forward and file an INAD is definitely what we're excited about," says CannPal Animal Therapeutics (ASX: CP1) founder and managing director Layton Mills.
An INAD (Investigational New Animal Drug) application in the US may not sound exciting to most, but in pharmaceutical development it signifies a leap seldom seen in cannabinoid drugs for animals or humans.
With the latest results from a dosing study of CannPal's cannabis-based drugs for dogs, founder Layton Mills says the company is ready to take this big step with the US Food and Drug Administration (FDA) in early 2019.
"It's not actually filing for approval of the drug, but it's the first time you have enough data to sit down with the FDA," he tells Business News Australia.
He says the process is very collaborative, and CannPal will be showing the positive results of its tests with cannabinoid impacts on genetic markers, while demonstrating the safety profile of the pain and inflammation drug (CPAT-01) while sharing development plans for the coming 18 months.
The FDA is expected to take these results and plans into account before subsequently making its own recommendations.
"As soon as you file an INAD you're hit with a sponsor fee which is around $100,000 per year, but we announced we'd get a waiver for through what's called a barrier to innovation provision," he says.
"This means that we're a small company with a good idea. So they'll actually waive that fee.
"Filing an INAD is actually pretty significant. There aren't too many companies globally that have filed an INAD for animal health or an IND for human health for the cannabinoid drug. They're few and far between."
He says much of the reason behind this lack of similar applications from US companies is the fact it's still illegal to hold the substance.
"It's hard to do research in the United States with these actives...a lot of people haven't had the opportunity to do it," says Mills, who will be a finalist in the Australian Young Entrepreneur Awards 2018 tomorrow on the Gold Coast.
"In the US you've got a lot of companies that are producing oil - not even testing it for stability - and putting it in the market."
He says what makes CannPal different to a lot of cannabinoid drug developers is its strong capitalisation.
"We still have very positive capital reserves; enough to get us through the development milestones that we've already indicated to market that we will be doing over the next year," he says.
"That leaves us in a pretty strong position financially, and we're also moving super quickly. Not many people in the world are seeing the sort of things that we are.
"We've looked at 59 dogs now between Phase 1A and 1B and we've seen some really exciting and interesting results, and some things that were unexpected as well in a positive way."
Mills sees a lot of encouragement in how cannabinoids are working inside the bodies of the dogs.
"We're using particular ratios of cannabinoids and comparing to other ratios, and we're seeing positive effects inside the body of the dog; how they're being absorbed for example. We're seeing things we're pretty certain not many people in the world have seen."
Gene expression studies so far have shown a clear cannabinoid impact in important pain and inflammatory pathways, which CannPal believes supports its proposed chronic pain claims for its proprietary formulation of CPAT-01.
The group is now working with a Melbourne-based integrated medical lab to find the drug's effects on chemokine and cytokines associated with the activated pain and inflammatory genes highlighted in the Phase 1 studies.
CannPal has also received ethics approvals to start testing CPAT-1 in cats, after the company recently announced it had entered into a research agreement with a leading feline veterinary research organisation to expand the testing program.
Cats represent more than 25 per cent of the companion animal drug market and CannPal believes there is a "clear unmet need for safe therapeutics" that can be used to their treat pain and imflammation for them. More 20 cats have been recruited for the study across varying weights and ages.
The animal phase of the study was originally planned for this quarter, but is now expected to commence early in 2019 across multiple research sites.
"Our vision is to be one of the first animal health Companies to provide veterinarians with GMP produced and regulatory approved cannabinoid-derived therapeutics for pets," Mills said in a release this morning
"We have been strict on resources and strong on creativity to ensure we remain well capitalized to continue with the development of CPAT-01 in 2019, which wouldn't be possible without the help and support of our experienced research partners."
CannPal's head of research and development, Dr Margaret Curtis, reiterated that the results were "very promising" with good absorption in healthy dogs.
"These studies have also shown that gene regulation associated with pain and inflammatory pathways in these dogs was positively influenced by treatment," she said.
"This gives us confidence in the effects of cannabinoids on key inflammatory markers associated with pain and arthritis.
"We are closely approaching readiness for submission of an INAD with the US-FDA and preparing for pilot clinical work to confirm the positive indications we have seen for CPAT-01 for the control of pain and inflammation in dogs with osteoarthritis."Never miss a news update, subscribe here. Follow us on Facebook, LinkedIn, Instagram and Twitter.
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