More than 48 Beagles and Foxhounds were recruited for the study across various weights and ages.
Importantly, no adverse events were reported in dogs across all treatment groups.
The gene expression studies so far have revealed clear cannabinoid impact in important pain and inflammatory pathways supporting the proposed pain and inflammatory control claims for CPAT-01.
CannPal is now working with a Melbourne-based integrated medical laboratory to identify the drug’s effects on key chemokine and cytokines that are associated with the activated pain and inflammatory genes highlighted in the phase I studies.
The results of this in conjunction with the gene expression data will support the dose justification for CPAT-01 prior to commencing the clinical program.
CannPal founder and managing director Layton Mills said: “I am very pleased at the speed in which we are progressing through the CPAT-01 development plan, but more importantly, the significant amounts of data we are collecting along the way.
“Our vision is to be one of the first animal health companies to provide veterinarians with GMP produced and regulatory approved cannabinoid-derived therapeutics for pets.
“We have been strict on resources and strong on creativity to ensure we remain well capitalised to continue with the development of CPAT-01 in 2019, which wouldn’t be possible without the help and support of our experienced research partners.”
Phase II study protocol development
The company has now generated significant data on the pharmacokinetic and gene expression profiles of cannabinoids in dogs.
This data will be used to commence the protocol development for the first phase II study, a pilot dose determination study in client-owned animals with osteoarthritis to clinically validate the effects seen in phase I studies.
CannPal is aiming to commence recruitment for this study in Q1 2019.
CPAT-01C cat study
The company has also received ethics approvals to commence the testing of CPAT-01 in cats.
Cats represent over 25% of the companion animal drug market and there’s a clear unmet need for safe therapeutics that can be used long-term to treat pain and inflammation in felines.
Over 20 cats have been recruited for the study across varying weights and ages.
The animal phase of the study was originally planned for Q4 2018 but is now expected to commence early in 2019 across multiple research sites.