Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) has completed its safety and efficacy study for DermaCann, an oral nutraceutical developed for healthy skin and immune function for dogs.
CannPal Head of R&D, Dr Margaret Curtis, said the treatment with two 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.
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adverse events reported throughout the trial and both DermaCann formulations were well tolerated, with no dogs being withdrawn from the study.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 company 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.
We’re extremely pleased to see such positive results from this study, which will support our authorisations for DermaCann in various markets,” Dr Curtis said.
“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.”