DERMAL INDICATIONS / CANINE PATIENTS
Numerous pharmacological, pharmacokinetic and toxicological studies of NK have been performed in dogs by Bridge Pharma.
This is of interest since dogs - like humans - often suffer from atopic dermatitis (AD). NK will mainly be administered orally to dogs. The initial daily dose will be higher during the first couple of days (“loading dose”) than thereafter (“maintenance dose”)
Two clinical Proof of Concept (PoC)-studies were performed in client-owned dogs:
One PoC study in dogs with AD used an initial loading dose of once-daily NK, administered for two weeks. PVAS (Pruritus Visual Analog Scale) scores were assessed by the dog-owners and the severity of AD was assessed by the veterinary investigators. Potent (P < 0.0001) therapeutic activities were demonstrated after three to four days of once-daily oral dosing of NK. It was concluded that the loading dose of NK in AD-dogs need to be used for less than one week in dogs.
A second PoC study was also performed in client-owned dogs with AD. Once-daily maintenance doses of NK were administered for four weeks. No loading doses were used in this study that relied on assessment of PVAS (Pruritus Visual Analog Scale) scores by the dog-owners. The PVAS scores demonstrated a potent NK-induced decrease in pruritus (P = 0.0004).
The daily doses of NK in both PoC-studies were significantly below the NOAEL for NK in a 4-week toxicity study in dogs (NOAEL = No Observed Adverse Effect Level). As also pointed out by the investigators, none of the observations by the dog owners referred to adverse effects of the test article (NK).
BRIDGE PHARMA, Inc.
Sarasota, FL 34242