After successfully testing its cannabis-derived pain formulation on a group of Beagles and Foxhounds, CannPal Animal Therapeutics (ASX:CP1) has begun a new phase of its study into determining safe dosages for pets.
CannPal declared the Phase 1A pharmacokinetic and safety study for the CPAT-01D formula a success after testing of 11 dogs showed 'excellent safety and tolerability' for the product.
"The study is designed to demonstrate cannabinoid pharmacology in dogs according to Good Laboratory Practice as a first step in generating pivotal data for regulatory submissions," says the company.
"It will also provide an initial indication of the dose range and tolerability at five times the estimated dose, in preparation for future pivotal safety studies required by regulatory bodies.
"Over 350 genetic markers are being analysed before and after consumption of cannabinoids to further support the understanding of the mode of action and effects of cannabinoids on pain and inflammation.
"This innovative approach in the pharmaceutical development of animal health products has potential to allow better understanding of the effects of cannabinoids in dogs in a shorter amount of time and with fewer animals."
CannPal plans to use results from testing at its NSW research facility to file an Investigational New Animal Drug application with the US Food and Drug Administration.
It is targeting the second half of calendar 2019 to conduct a pilot dose determination study that will test family pets with osteoarthritis.
"It is excellent to see the significant progress we are making with CPAT-01, and the quick turn-around time between Phase 1A and Phase 1B," says CannPal founder and managing director Layton Mills.
"CPAT-01 has the potential to offer a new solution for dogs that suffer from painful conditions and we look forward to rapidly progressing through Phase 2 of this exciting research at the completion of our Phase 1 studies."
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Business News Australia