Special Report: Animal health company CannPal has released data from a study into its hemp-derived cannabidiol (CBD) nutraceutical for skin and immune support in dogs, and the results will open markets around the world for the ambitious biotech.

Results from animal health company CannPal Animal Therapeutics’ (ASX:CP1) clinical study into its oral skin and immune support treatment for dogs is set to open doors in markets around the world.

Managing director Layton Mills says the results from the study, released today, showed substantial improvement in dogs with canine atopic dermatitis, which will be used to support the Company’s commercialisation efforts for DermaCann, CannPals hemp-derived CBD nutraceutical.

“we’ll be able to use this exciting data to support our registration for DermaCann in various regulated markets including Australia, and we’re in advanced discussions with partners to commercialise the product in other regions where registration may not be required, due to the relaxing of regulations for hemp-derived CBD.” Mills told Stockhead.

“We believe this is the first clinically validated oral nutraceutical for skin health in dogs containing CBD, which is a really exciting opportunity for the Company.

“We have a product that could intersect both the canine atopic dermatitis market, and the large CBD market which is growing at a phenomenal rate, but lacks any clinically validated products.”

DermaCann is designed to support any dog with their skin and immune health function, but Mills says to see such a substantial impact on dogs with tricky-to-treat Atopic Dermatitis was a very good sign.


Positive results

The study included 13 dogs suffering from Atopic Dermatitis, a condition that is worth over $1.5bn globally in animal pharmaceutical and nutraceutical products and affects about 15 per cent of dogs.

Canine dermatologists measured changes in dogs before and after treatment using the Canine Atopic Dermatitis Extent and Severity Index (CADESI-4), a gold standard method used to grade inflammation and skin lesions in dogs with atopic dermatitis and found substantial improvements in dogs using DermaCann.

There was an average reduction of 51 per cent for dogs on treatment, compared to a slight increase observed in the placebo group between days 0 and 56.

“We’re extremely pleased to see such positive results from this study. DermaCann’s well absorbed CBD was clinically safe when used in these dogs with atopic dermatitis. Treatment substantially reduced skin redness and sores, with an average reduction in CADESI-4 scores of 51% versus placebo dogs. This data complements our solid product stability profile and user safety research to support authorisation in various markets, providing veterinarians with a novel product to support healthy skin and immune function in dogs” said CannPal head of R&D Margaret Curtis” said CannPal Head of R&D, Margaret Curtis.

Mills said DermaCann has been in development for close to 3 years now, and in that time, they’ve built a robust product dossier with a novel formulation, compelling dataset and strong Intellectual Property.


Happy doggies

Dosing for the safety and efficacy study started in Q4 2019 with 30 dogs expected to participate in the trial. However, due to the social distancing measures implemented by the Australian government in response to COVID-19, CannPal made the decision to finalise the study with 13 dogs having successfully completed treatment.

The treatment is a combination of CBD and other proprietary plant-based active ingredients in a patented formulation.
Despite the reduced number of animals in this study, the differences between placebo and treatment indicate substantive and clinically relevant results.

Fig 1: Average CADESI-4 scores in dogs treated with either placebo or DermaCann

Fig 1: Average CADESI-4 scores in dogs treated with either placebo or DermaCann® (DermaCann formulation 1 (DC-1) or DermaCann formulation 2 (DC-2)). Results from pre-treatment (day 0) to day 56. Lower score = treatment benefit.

Canine blood plasma samples were also taken from dogs at Day 0, Day 28 and Day 56 to assess the impact of treatment on various inflammatory and immune related biomarkers.

Ex-vivo biomarker analyses confirmed a reduction in multiple chemokines and cytokines in canine blood samples associated with immune and inflammatory responses in dogs, when comparing DermaCann® treated dogs with those on placebo. The most notable were Chemokine Ligand 1 (CXCL1) and Chemokine Ligand 2 (CCL2).

Both biomarkers are biologically relevant to the mode of action of effective treatments for Atopic Dermatitis in humans, supporting a potential mode of action for DermaCann® in dogs.

Fig 2: Changes in CXCL1 and CCL2 expression in dogs with atopic dermatitis

Fig 2: Changes in CXCL1 and CCL2 expression in dogs with atopic dermatitis after treatment with 2 different DermaCann® formulations, or placebo, as assessed by ex-vivo biomarker analyses in canine blood plasma samples.


Designing a strong study

The study design was a randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of two DermaCann formulations in dogs with dermatological skin conditions, using different sources of cannabidiol extracted from the hemp plant, compared to placebo. Eight dogs were allocated to the DermaCann treatment groups and five were allocated to placebo.

Dogs were dosed twice daily over a period of 56 days, with veterinary and owner assessments conducted on all dogs on or around Day 0, Day 28 and day 56.

Clinical assessments were completed by dermatology specialist veterinarians using the CADESI-4 model to assess skin lesions in multiple areas classically affected by canine atopic dermatitis. Assessments of skin and coat health were also completed by the dermatologists.

There were no significant adverse events reported throughout the trial and both DermaCann formulations were well tolerated, with no dogs being withdrawn from the study.

This article was developed in collaboration with CannPal Animal Therapeutics, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.