TriviumVet are delighted to announce the publication of a clinical study assessing our first product in development, a gastric acid suppressant to treat gastric ulceration in dogs.
Unmet treatment need
Worldwide there are no veterinary registered pharmaceutical treatments for gastric ulceration in dogs. Gastric ulceration is a well-recognized disorder in canine veterinary practice, often arising secondary to non-steroidal anti-inflammatory drug (NSAID) use. The goal of pharmacological intervention to facilitate the healing of gastric ulceration is elevation of gastric pH. At present, human gastric acid suppressants such as proton pump inhibitors (PPIs) are used off label for dogs but the need for a veterinary approved PPI has long been recognized by the veterinary community. It is appropriately highlighted by an ACVIM 2018 consensus statement calling for pharmaceutical companies to address this unmet need.
“not a single agent (gastro protectant) is FDA (or European Medicines Agency – EMA)-approved for dogs…Clearly, the pharmaceutical industry should become involved in evaluating these drugs.” – American College of Veterinary Internal Medicine Consensus Statement 2018
CEO Louise Grubb comments “At TriviumVet we strive to produce treatments for unmet clinical needs and with our first product we feel we will deliver an extremely valuable product for veterinarians in the US and EU markets – our initial research has confirmed that over 90% of veterinarians are likely to use our product once it is approved by the regulators”.[1]
Study Results
The purpose of this newly published study was to evaluate the efficacy of TriviumVet’s 10 mg omeprazole capsule currently under development in increasing gastric pH in healthy laboratory dogs. It was hypothesized that encapsulated omeprazole would significantly increase the gastric pH compared to placebo and reach pH goals extrapolated from human medicine for the treatment of esophagitis and duodenal ulceration. The study was a randomised, blinded, 2-way crossover study.
It was found that intragastric pH was significantly higher in dogs during treatment with the TriviumVet omeprazole product than during the placebo period. Furthermore, intragastric pH was maximally increased on Day 2 of treatment, indicating a rapid onset of action of the product. The researchers concluded that TriviumVet’s 10 mg enteric-coated omeprazole capsule is an effective gastric acid suppressant in healthy dogs.[2]
Lead study investigator and veterinary gastroenterologist Dr. Katie Tolbert welcomed the results of the study: “There has long been a requirement for further research into PPIs specifically for the use of our canine patients. I am excited to see a product, which has been demonstrated to be highly effective and is in development for regulatory approval, to become available to veterinarians to prescribe to their patients.”
Further studies and NSAID research
This study is the latest in a series of research projects relating to gastric ulceration in canines as well as potential treatments and duration of treatment. TriviumVet CTO and veterinarian Stuart Fitzgerald comments “We are delighted to see such strong pharmacodynamic data for our first product. In addition to this study, we have a number of others that are underway or awaiting publication which provide significant, clinically relevant information on the required duration of treatment for gastric ulcers and the impact of chronic NSAID use in dogs.”
Chronic NSAID use in dogs
One of the leading causes of gastric ulceration in dogs is chronic NSAID use; in recent years the estimated prevalence of gastric ulceration has been increasing in line with a growing trend of chronic NSAID use in dogs suffering from illnesses such as osteoarthritis and cancer. Small animal NSAID sales increased 13.5% from 2019 to 2020[3] illustrating the growing usage across veterinary medicine.
In a recent study published in the Journal for Veterinary Internal Medicine by a team of veterinary gastroenterologists presented findings that 83% of dogs receiving long term NSAIDs developed gastric or duodenal ulceration[4]. They concluded; “Subclinical GI erosions are more common in dogs receiving chronic treatment with NSAIDs than in control dogs with chronic GI disease, suggesting that NSAIDs be used with caution, particularly in dogs with comorbidities predisposing them to GI ulceration.”
The full PDF of the TriviumVet study “A prospective, randomized, masked, placebo-controlled crossover study for the effect of 10 mg omeprazole capsules on gastric pH in healthy dogs” can be found here jvim.16061 A prospective randomized masked placebo controlled crossover study for the effect of 10mg omeprazole capsules on gastric pH in healthy dogs
The full PDF for an independent study on “Prevalence of gastrointestinal lesions in dogs chronically treated with nonsteroidal anti-inflammatory drugs” can be found here Prevalence of gastrointestinal lesions in dogs chronically treated with NSAID drugs
TriviumVet company information:
TriviumVet, a veterinary research and development company based in Co. Waterford, Ireland, develops a range of new animal drugs and diagnostics for companion animals.
CEO Louise Grubb comments “Our mission at TriviumVet is to bridge the treatment gaps in companion animal healthcare by addressing unmet clinical needs. The challenges of Covid-19 have made the role our animals play in our lives even more important. Our pets are part of our family and our expectations are that they live longer, healthier lives and when they get sick, we want the best healthcare solutions.”
TriviumVet identifies gaps in available treatments and develops new, safe and effective therapies and diagnostics. Globally, expenditure on all aspects of pet ownership, from healthcare to maintenance and gifting, has been in growth. More and more people are purchasing pets and the role of the pet in our lives has evolved. The pharmaceutical segment accounts for the largest percentage of revenues in animal health with roughly 40% of the overall market. Sales of animal pharmaceuticals were $19.9 billion in 2019 and are expected to increase to $26.9 billion by 2024 with a five-year compound annual growth rate (CAGR) of 8.6%.
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