CannPal Animal Therapeutics Limited [ASX CP1] is researching and developing medicines derived from cannabis to treat animals in a safe and ethical way. The company is targeting the very large North American and European companion animal health market.
CannPal’s latest headline news is a decision by the US FDA to issue a sponsor fee waiver on the company’s lead drug in development as pain control in dogs (CPAT-01).
The waiver covers an annual drug sponsor fee which is currently priced at US$75,150 and can be renewed each financial year. CannPal may also be eligible for reductions in other fees such as the drug application fee which can cost in excess of US $300k.
The cannabinoid system in animals and humans is a mechanism by which cells in the body signal to each other though chemical transmissions and reception. There is plenty of anecdotal evidence and a growing body of clinical evidence demonstrating the efficacy of cannabinoids THC and CBD interrupting cell to cell signaling associated with the sensation of pain and inflammation.
Many cannabis based dietary supplements for pets are currently being marketed to pet owners globally, however a recent investigation by the FDA found that some of these supplements contain little if any active ingredient, or amounts different to the label claims. Others provide no assurance of correct dosage.
Pet owners and regulators are presumably very keen to see veterinary products on shelves that assure quality and the delivery of appropriate cannabinoid dosages.
A pivoting point for cleaning up the industry and realising further legislative and regulatory reform is the completion of properly structured clinical studies and the tabling of peer reviewed evidence. This is why the FDA’s decision to issue a user fee waiver in support of programs such as CannPal’s CPAT-01 is so significant.
The CPAT-01 Phase 1b study has enrolled 48 dogs following a successful Phase 1a component which showed excellent safety and tolerability. Over 350 genetic markers will be analysed before and after consumption of cannabinoids to further support the understanding of the mode of action and effects of cannabinoids on pain and inflammation.
CannPal plans to take the results from the recently commenced Phase1A and 1B studies to file an INAD (Investigational New Animal Drug) application with the FDA prior to the FY19 financial year.
CannPal’s Founder and Managing Director Layton Mills stated:
Receiving this fee waiver not only provides additional cost savings for the company but also further validates our focus on following regulatory protocol and seeking added value opportunities for our shareholders. The Phase 1B study is now well underway and we looking forward to continuing on our path of developing safe and scientifically-proven treatments for companion animals.”