CannPal Animal Therapeutics (ASX: CP1) is a step closer to commercialisation after its oral hemp-based CBD nutraceutical DermaCann was shown to “substantially” reduce atopic dermatitis in dogs during a recent clinical study.
The company has developed DermaCann to promote skin health and immune function in canines.
During a clinical trial over eight weeks, two similar DermaCann formulations and a placebo were used to treat dogs.
The trial showed canines treated with DermaCann had an average reduction of 51% on the Canine Atopic Dermatitis Extent and Severity Index (CADESI-4), while the placebo group had a slight increase in symptoms.
According to CannPal, the CADESI-4 index is a “gold standard” method used to grade skin lesions in clinical trials to evaluate the effectiveness of treatments in dogs with atopic dermatitis.
In addition to reducing the severity of atopic dermatitis, the trial found DermaCann was well tolerated with no significant adverse events.
Dosing for the study began in the December quarter last year with the company planning to recruit 30 dogs.
However, with the advent of COVID-19 and social distancing measures, CannPal reduced the trial number to 13 dogs.
The company claims that despite the reduced numbers, the differences between placebo and treatment revealed “substantive and clinically relevant results”.
“We have had DermaCann in development for close to three years now, and the result of that work is a safe and differentiated CBD product for dogs with a compelling dataset and strong intellectual property,” CannPal managing director Layton Mills explained.
“To our knowledge, this will be the only clinically validated oral CBD pet nutraceutical for skin health in dogs, and we look forward to furthering our commercial discussions for this exciting new product,” he added.
With more positive clinical results under its belt, CannPal will use them to support registration of the product in multiple markets as a nutraceutical for healthy skin and immune function for dogs.
Additionally, CannPal said it has used the data to strengthen its intellectual property portfolio and has filed a second PCT international patent application.
The company anticipates this will be granted and establish the company’s patent through to mid-2040.
To register the product in Australia and New Zealand, CannPal will complete its Target Animal Safety study, which is scheduled to begin during the second half of this year.
However, the company is already in discussions with various health partners regarding commercialising DermaCann in markets that may not require registration due to more relaxed regulations for hemp-derived CBD.