As per ASX announcement on 12th December 2018, CannPal Animal Therapeutics Limited (ASX:CP1), animal health care company, has reported significant results in completing the dosing and live phase observations for its clinical Phase 1B study for CPAT-01, leading inflammatory control drug for dogs.
CannPal Animal Therapeutics is a pet pharmaceutical company researching the benefits of medical cannabis with an initial focus on cats and dogs.
Phase 1A study
CannPal won the import license from Australian Government’s Office of Drug Control in November 2017, allowing it to obtain cannabis formulations for CPAT-01 study. It then launched the robust Phase 1 study in 2 stages to determine the pharmacokinetic and underlying gene expression profile of company’s cannabinoid-derived formulations in the canine body. 11 dogs were selected for the purpose of analysis, with 8 receiving treatment and 3 placeboes. 1st phase was completed by April 2018.
Major observations of Phase 1A study
- Presence of clear molecular profile signatures in important pain and inflammatory pathways.
- Generation of new data to support additional intellectual property claims.
- Well tolerated formulations at 0.3, 1x and 5x dose.
- Identification of potential safe dose range with optimal pharmacokinetics to be used for a pilot study in osteoarthritic dogs.
Phase 1B study
CannPal began the Phase 1B study in September 2018. This is in continuation to safety study which started earlier in 2018 and showed excellent safety and tolerability for CPAT-0. 48 beagles and foxhounds of both sexes across various age and weight groups were selected for the study. The company reported that the study posed no danger to dogs across the breeds and following were the highlights:
- Obtaining pivotal GLP (good laboratory practices) pharmacokinetic data to support regulatory submissions.
- Receiving early indication of the dose range for Phase 2 pilot studies..
- Confirming cannabinoid impact on identified gene expression targets seen in Phase 1A.
- Identifying tolerability at up to 5x estimated dose of THC and CBD.
The Company has generated significant data on the pharmacokinetic and gene expression profiles of cannabinoids in dogs, which will be used to commence the protocol development for the first Phase 2 study to clinically validate the effects seen in Phase 1 studies by Q1 2019.
Post successful results in Phase 1 and Phase 2 study, CannPal is filing an INAD (Investigational New Animal Drug) application with the FDA (Food and Drug Administration) in early 2019. It was also granted an official sponsor fee waiver on 9th November 2018 from the FDA/CVM under the significant barrier to innovation provision of the FDA’s Animal Drug User Fee Act (ADUFA) of 2003.
CPAT-01C Cat Study
CannPal has also ventured into a research agreement with a leading feline veterinary research organisation to expand the CPAT-01 development program to include cats, a growing opportunity in the animal health market. The testing of CPAT-01C Cat Study, canine pain and inflammatory drug is expected to commence by early 2019
Although CannPal’s stock is trading on the downside this year with a YTD return of -48.78% but the stock is worth keeping a close watch post the major announcement of clinical study successful results. The stock was up 4.35% on December 12, 2018, 2 PM AEST.
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