DermaCann was well tolerated by all dogs on treatment, with no significant adverse events.
Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) is pleased to announce the completion of its safety and efficacy study for DermaCann®, an oral nutraceutical developed for healthy skin and immune function for dogs.
Treatment with 2 similar DermaCann® formulations resulted in a substantial improvement in CADESI-4 scores, with an average reduction of 51% for dogs on treatment, compared to a slight increase observed in the placebo group between days 0 and 56.
CADESI-4 (Canine Atopic Dermatitis Extent and Severity Index) is a gold standard method used to grade skin lesions in clinical trials to assess the impact of treatments in dogs with Atopic Dermatitis.
Dosing for the safety and efficacy study commenced 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.
Despite the reduced number of animals in this study, the differences between placebo and treatment indicate substantive and clinically relevant results.
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 associated with immune and inflammatory responses in dogs when comparing blood samples taken from 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.
The study design was a randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of two similar DermaCann® formulations in dogs with dermatological skin conditions, using different sources of cannabidiol extracted from the hemp plant. 8 dogs were allocated to the DermaCann® treatment groups, and 5 had been 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 validated 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 and dog owners.
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.
CannPal will use the positive results from this trial as supportive efficacy data for the registration of DermaCann® in multiple markets as a nutraceutical for healthy skin and immune function for dogs.
The data has also been used to strengthen CannPals Intellectual Property portfolio, with the filing of the Company's second PCT international patent application. This application is expected to establish an exclusivity period for the Company's DermaCann® formulation extending to mid-2040.
CannPal Head of R&D, Dr Margaret Curtis :
"We're extremely pleased to see such positive results from this study, which will support our authorisations for DermaCann® in various markets. This data complements our solid product stability profile and user safety research, to provide veterinarians with a novel, data-supported robust product for healthy skin and immune function in dogs."
CannPal Managing Director, Layton Mills:
"We have had DermaCann® in development for close to 3 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. 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 commercialisation discussions for this exciting new product."
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