31st July 2019: Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) ("CannPal" or "the Company") is pleased to announce the commencement of the Phase 2A pilot dose determination study for the Company's lead drug candidate, CPAT-01, in development for pain and inflammation control in dogs.
The clinical trial is an 8 week randomised, double-blind, placebo-controlled study in dogs, to assess the effects of THC and CBD in dogs diagnosed with osteoarthritis. 60 dogs are expected to participate in the trial.
12 veterinary clinics in Australia have been enrolled for the study with 6 across NSW and 6 across Queensland. Dog recruitment has commenced, with canine assessments for first patients already underway in NSW.
The cllinical trial material for the study was supplied by leading Canadian cannabis licenced producer, Aphria, and first patient dosing is expected to commence in August 2019.
The Phase 2 study follows a successful Phase 1 research program which provided the Company with a significant pre-clinical data pack for the drug including data in 59 dogs spanning across pharmacokinetics (fasted and fed), safety, inflammatory biomarkers, gene expression and early dose response data.
This data pack will be used to file the Company's INAD (Investigational New Animal Drug) application with the FDA/CVM (Food and Drug Administration/Centre for Veterinary Medicine), which is expected to be filed in August 2019
CannPal's Founder and Managing Director, Layton Mills:
"I'm extremely pleased to commence our Phase 2 program for CPAT-01 with the start of our pilot dose determination study. This trial is a globally significant milestone, as it represents regulatory and development progress that is yet to be matched by an animal health Company developing cannabinoid-derived products for pets."
About CannPal Animal Therapeutics
CannPal Animal Therapeutics Limited (ASX: CP1) is a pharmaceutical-focused animal health Company researching the benefits of medical cannabis for companion animals.
CannPal is researching and developing medicines derived from cannabinoids to provide veterinarians with clinically validated and standardised therapeutics to treat animals in a safe and ethical way.
CannPal has identified a significant opportunity to benefit from the rapidly growing medical cannabis and health markets by developing innovative therapeutics derived from the cannabis plant. The Company is working closely with regulatory authorities and veterinary research organisations conducting clinical trials to commercialise therapeutic products that will meet regulatory approval and support the health and well-being of companion animals.
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