CannPal Animal Therapeutics Limited announced 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 Fourth Quarter 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. Study design: 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. The Company still intends on completing its Target Animal Safety study for DermaCann®, which is a regulatory requirement for the registration of the product in Australia and New Zealand and anticipates a commencement date for this trial in H2 2020. CannPal has also advanced discussions with various animal health partners to progress the commercialisation of DermaCann® in markets that may not require product registration due to the relaxing of regulations for hemp-derived CBD.