CannPal Receives Ethics Approvals for Phase 1B Study in Dogs
Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) (“CannPal” or “the Company”) is pleased to announce it has received ethics approval to advance its clinical development plans for CPAT-01, a pain control being developed for cats and dogs.
- CannPal has received ethics approvals to advance the development of its lead drug candidate, CPAT-01, a pain control in dogs
- Phase 1B of the Pharmacokinetic and Safety study is set to commence in August 2018, with 48 dogs recruited for the study
- The study design will be assessing additional pharmacokinetic and safety parameters, including tolerability at 5x estimated dose, and early dose ranging confirmation
- The Company is also evaluating the cannabinoid impact on identified gene expression targets to identify underlying mechanisms of action
Phase 1B is a continuation of research into CannPal’s lead drug candidate, CPAT-01, an innovative cannabis-derived pain control for companion animals. The Company recently announced the completion of Phase 1A of the Pharmacokinetic and Safety study, and was pleased to note that the formulations used in the study were well-tolerated, with no adverse events reported and significant levels of absorption achieved.
The ethics approval is for Phase 1B of this study, which will involve 48 dogs and is set to commence this month. Phase 1B endpoints are to assess additional pharmacokinetic and safety parameters and assess tolerability at 5x the estimated dose.
The Company will also be completing pathway-focused gene expression analysis as part of this study, using laboratory-verified PCR (Polymerase Chain Reaction) assays to identify potential underlying mechanisms of action for treating pain and inflammation in dogs.
CannPal is in the final stage of completing the protocols for Phase 1B and has the necessary clinical trial material ready to conduct the study, which was imported earlier in 2018. The Company is pleased to report a quick turnaround time between the completion of Phase 1A in May and further research commencing in August.
Managing Director, Layton Mills
We’re very pleased to have received ethics approval for our Phase 1B study for CPAT-01. The speed with which CannPal has moved to the next stage of our research is indicative of our commitment to progressing our clinical development plans on time. We look forward to further updating the market on the results of this study, which are expected in Q3 2018.