AusCann Group Holdings Limited updated the market on key clinical veterinary and owner scoring results for the CannPal CPAT-01 Pilot Phase 2A study supporting 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 USD 1 billion 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 8 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. Clinical Veterinary and Owner Assessment Models: Veterinarians completed a 5-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). Scores were analysed separately and pooled together and change over time was assessed at 0, 14, 28, 42 and 56 days with comparisons made between treatment groups, all CPAT-01 treatment groups combined and placebo, as well as within groups. Key Clinical Veterinary Scoring Results (VLS): 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 high 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. Key Clinical Owner Scoring Results (CBPI and COI): The CBPI followed a similar outcome to the veterinary scoring with all groups showing improvement over time. While there was no significant difference between groups for CBPI, the within group analysis showed a significant reduction (P<0.1, P<0.05) in pain and interference associated with pain from baseline for all treatment groups over 56 days. Considering the within group analyses, significant improvements (P<0.05) in the CBPI can also be seen in the first 14 days for the lowest CPAT-01 dose group and all CPAT-01 groups combined, while the placebo group change was not significant over that same 14-day period. The high CPAT-01 dose group numerically recorded the great reduction in CBPI on day 42 however the high variability within and between groups prevented this from reaching significance. A higher than expected placebo effect and the high variability of the responses in the survey meant that there was no significant separation between groups in the latter part of the study for CBPI. As with the CBPI, all groups showed substantial improvements in the COI and were most noticeable in the first 14 days of treatment, where a significant improvement (P<0.05) in total COI scores for all CPAT- 01 treatment groups combined and compared with baseline was observed, while over the same period no significant improvement in the placebo was seen. The Company was pleased to note that the Quality of Life (QOL) section of the COI scoring appeared to have the most marked effect, again most noticeably at day 14 day of treatment where all groups combined showed a statistically significant (P<0.01) improvement while statistical significance was not observed in the placebo group.