Cannabinoid Animal Drug Advances to Next Phase of Development
Results from a pharmacokinetic and safety study of the first cannabinoid-based pain medication have been positive, and the next phase of the study is set to begin.
(August 6) — CannPal Animal Therapeutics has received ethics approval to advance the development of CPAT-01—a cannabinoid drug intended to control pain in dogs.
The company will now move into phase 1B of the drug’s pharmacokinetic and safety study.
“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,” CannPal Managing Director Layton Mills said.
For phase 1B, slated to start this month, the company has recruited 48 dogs to help them assess additional pharmacokinetic and safety parameters of the drug—including tolerability at 5 times the estimated dose, early dose ranging confirmation, and the cannabinoid impact on identified gene expression targets.
CannPal expects to report results of the study in Q3 of this year.
(June 30) — The use of cannabinoids in veterinary medicine has been a much discussed and debated topic as of late. As more pet owners become curious about the potential benefits of cannabinoid-based products for their pets—from pain support to anxiety relief—veterinarians have been tasked with delving further into the research and education available on the topic. And the race is on to get cannabinoid-based products to market.
The 2 most well-known cannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC). To date, all animal-based cannabinoid products contain only CBD. Phyto Animal Health, for example, has a robust line of CBD products that includes tinctures and bedding, and CBD Health Co., a traditionally human-focused company, started offering a line of hemp-based products for pets earlier this year.
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Most recently, CannPal Animal Therapeutics, an Australian firm, received favorable results from a pharmacokinetic and safety study for a cannabinoid drug intended to control pain in dogs. This "first-in-dog use" proprietary oral cannabinoid formulation, known as CPAT-01, contains both CBD and THC .
The phase 1A study was conducted on 11 male beagles—8 treated and 3 control—of varied ages and weights. The results indicated excellent safety profiles seen at the initial target dose, no adverse events, and significant absorption in its current formulation.
The study’s success opens the door for CannPal to proceed with preparation for phase 1b of the study, with 48 dogs, which is expected to commence in the fall. According to an interview with AnimalPharm, the company anticipates that the product could be ready for commercialization in 2021.
Now that the CPAT-01 studies are underway in dogs, the company is exploring how to expand the drug to also be used in cats, which CannPal calls “a significantly unmet need in the companion animal drug market.”