Animal health company CannPal Animal Therapeutics Limited (ASX:CP1) (“CannPal” or “the Company”) is pleased to update the market on the recently completed Pharmacokinetic and Safety study for CPAT-01, the Company’s lead pharmaceutical in development as a pain control for dogs.
- CannPal has successfully completed Phase 1A of the Pharmacokinetic and Safety Study for CPAT-01 with all endpoints being met
- The Company has filed a new provisional patent application with the Australian Patent Office covering the dosages and cannabinoid ratios used in the study
- The Company is in the process of finalising the protocol for Phase 1B which is expected to commence in Q3 2018
- CannPal is now expanding the CPAT-01 development plan to include cats, which will broaden the potential of the drug candidate
The Company is delighted to announce that it successfully completed Phase 1A of the study for CPAT-01 in which all endpoints were met. The start date was March 31st 2018 and the animal phase finished on the 13th of April 2018, with the laboratory phase concluding on 1st May 2018.
The formulations used in the study were well tolerated, with no adverse events reported, and significant absorption of the actives observed in the drug plasma concentration analysis.
Phase 1A Overview
“First in Dog” use of proprietary oral cannabinoid formulations containing both THC (Tetrahydrocannabinol) and CBD (Cannabidiol)
- Pharmacokinetic and Safety study
- Included 11 dogs (8 treated/ 3 control)
- Male Beagles; varied age/weight
- Endpoints: i) No adverse events ii) Determination of dose proportionality iii) Indications of expected Tmax, Cmax, AUC and Half-Life iv) Visual Observations
Phase 1A Results
- Excellent safety profiles seen at the initial target dose
- No adverse events were observed at the dosages administered
- All observational endpoints were met
- CPAT-01 showed significant absorption in its current formulation
The success of Phase 1A has allowed to Company to move forward with preparation for Phase 1B of the study, with 48 dogs enrolled. CannPal is in the process of finalising the protocol for this study which is expected to commence in Q3 2018.
The Company is also delighted to announce that it has lodged a new provisional patent application with the Australian Patent Office (IP Australia), which was filed on Friday 15th of June 2018.
The patent application covers specified dosages and ratios of cannabinoids, containing levels of THC (Tetrahydrocannabinol) that are safe for use in dogs. The Company identified a range of blood plasma concentrations that have shown desirable safety profiles, giving the Company indications of a potential therapeutic window to be used in future studies.
The promising safety profile observed in the Phase 1A study has also given management confidence to expand the development plan of CPAT-01 in cats, with ongoing conversations with research partners to commence Pharmacokinetic studies in 2H 2018.
Cats share in almost 30% of the veterinary pain market and there’s a significant unmet need for safe feline pain treatments. There are only two NSAID’s (Non-steroidal anti-inflammatory drugs) approved to treat pain in cats in the United States, and none for long term use.
The success of CannPal’s first live phase study is a significant milestone for the Company as it shows we are capable of setting and hitting research milestones to drive shareholder value. We are looking forward to commencing Phase 1B of this study and expanding the market potential of CPAT-01 with research into cats, a significantly unmet need in the companion animal drug market.