AusCann Group Holdings Limited (ASX: AC8) has received the full analysis of clinical pain and lameness results from a world first Phase 2A Pilot study for CPAT-01, a cannabinoid-based veterinary medicine developed by CannPal Animal Therapeutics Ltd for pain and inflammation in dogs.
The results for the CannPal CPAT- 01 Pilot Phase 2A study support the safe and effective use of the product in dogs with osteoarthritis.
CPAT-01 is a standardised pharmaceutical product derived from natural THC and CBD extracts, formulated into a liquid oral solution to provide veterinarians with a safe and effective veterinary medicine for the treatment of pain and inflammation in dogs.
The veterinary pain and inflammation market is worth over US$1b globally and there is a need for viable treatment alternatives for dogs, particularly the elderly and compromised dogs where current treatments for pain and inflammation may be undesirable due to their potential negative side effect profiles or lack of effect.
Phase 2A Study Design
The study was a world first randomised, double blind, placebo-controlled dose ranging study, in which client owned dogs diagnosed with osteoarthritis were assigned to 1 of 4 treatment groups (Placebo, 0.27mg/kg, 0.54mg/kg and 0.9mg/kg cannabinoids) and dosed twice daily over a period of eight weeks.
The study protocol included several subjective pain, mobility and quality of life (QOL) assessments as well as objective measures of a range of biomarkers and clinical safety outcomes.
The recruitment target for the trial was 60 dogs, however, substantial slowing in enrolment due to the impact of COVID-19, and the social distancing measures implemented in Australia, led CannPal to the decision to finish the study with 46 dogs having completed treatment.
Veterinarians completed a five-part lameness assessment in conjunction with each physical examination of the dogs in the study at 0, 28 and 56 days. The Vet Lameness Scoring (VLS) included a review of clinical lameness, joint mobility, evenness of weight bearing, pain on palpation of the joint and an overall impression of the dog by the vet.
Scores were analysed separately and pooled together and change over time was assessed at 28 and 56 days with comparisons made between and within CPAT-01 treatment groups and placebo, as well as all CPAT-01 treatment groups combined.
Owners also completed a number of pain and activity scoring assessments every 2 weeks during the treatment period, including the CBPI (Canine Brief Pain Inventory) the COI (Canine Orthopaedic Index) and the HAS (Hudson Activity Scale).
A total reduction in veterinary lameness scoring was observed in all dogs treated with CPAT-01, showing improvement over time which was numerically better for treated dogs compared with placebo.
For within group analysis compared with baseline, there was a significant improvement for the highest CPAT-01 dose groups (P<0.1, P<0.05) and all CPAT-01 groups combined (P<0.05) over 56 days, which was not observed in the placebo group.
Placebo dogs had worse mobility after 56 days of treatment, whereas treated dogs had improved and this improvement was significant (P<0.1) for the middle CPAT-01 dose group. A test for dose trend in joint mobility was also significant which indicates that there was a positive dose response to CPAT-01 treatment for joint mobility.
The CBPI followed a similar outcome to the veterinary scoring with all groups showing improvement over time.
The data generated from this study will help inform the design of the company’s ongoing development programme, and AusCann has re-commenced drafting a formal request for a PSC (pre-submission conference) with the FDA/CVM (Food and Drug Administration, Centre for Veterinary Medicine).
The meeting will be used as an opportunity to share the Company’s Phase 1 and Pilot Phase 2A data generated from this study and receive formal guidance on its ongoing U.S development and regulatory plan for CPAT-01.