Animal health firm CannPal Animal Therapeutics Limited (ASX: CP1) is testing the company’s lead drug candidate CPAT-01 for pain and inflammation control in dogs.
The company started a Phase 2A pilot dose determination study for CPAT-01. The clinical trial is an eight-week randomized, double-blind, placebo-controlled study to assess the effects of THC and CBD in dogs diagnosed with osteoarthritis.
The trial is expected to involve 60 dogs, and 12 veterinary clinics in Australia have been enrolled for the world-first study with six across New South Wales and six across Queensland. Dog recruitment has commenced, with canine assessments for first patients already underway in NSW.
Aphria is supplying the clinical trial material for the study, and first patient dosing is expected to begin in this month.
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 candidate, including data in 59 dogs spanning across pharmacokinetics (fasted and fed), safety, inflammatory biomarkers, gene expression and early dose-response data.
The 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 this month.
“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,” CannPal’s Founder and Managing Director Layton Mills stated.