CannPal Animal Therapeutics Limited issued a press release announcing that it has commenced a Phase 2A pilot dose determination study for CPAT-01, its lead drug candidate. The drug is being developed to control the development of pain and inflammation in dogs.
Phase 2 follows a successful Phase 1 research program. The first phase provided the company with a pre-clinical data pack for the drug candidate, which were 59 dogs. The pack included data on pharmacokinetics, gene expression, early dose-response, and inflammatory biomarkers. The company will file an INAD application with the FDA/CMV using the data pack.
The press release indicates that 60 dogs are expected to participate in the 8-week randomized double-blind placebo-controlled study, which will review the impact of CBD and THC in dogs diagnosed with arthritis. Enrolled in the study are 12 veterinary clinics in Australia. Aphria, a cannabis company, is supplying the trial material.
Layton Mills, the Founder and Managing Director of CannaPal, shared in the press release,
“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.”