IHS Markit feature: TriviumVet gearing up for pet pipeline launches to bridge therapeutic gaps

TriviumVet_gearing_up_for_pet_pipeline_launches_to_bridge_therapeutic_gaps

In case you missed it the first time around you can read the FULL ARTICLE here where IHS Markit’s Sian Lazell caught up with TriviumVet CEO Louise Grubb

Ireland’s TriviumVet is a therapeutics and diagnostics start-up targeting a range of unmet needs in companion animal health. Having weathered the COVID-19 pandemic, the company is now aiming to take its lead gastrointestinal candidates to market next year. IHS Markit Animal Health analyst Sian Lazell spoke to founder and chief executive Louise Grubb about the firm’s pipeline potential and its goal to secure industry partners. Irish start-up TriviumVet is eyeing the pathway to commercialization for its pipeline of pet therapeutics. The company has developed a range of candidates targeting gastrointestinal (GI) disease, cardiac disease, neuropathic pain and kidney disease, as well as a diagnostic for dogs. The firm’s chief executive and founder Louise Grubb previously established Irish pet nutraceutical business NutriScience over two decades ago. Although the business would eventually be sold to Swedencare, the core premise of using state-of-the-art healthcare products and applying them to animal health would be key in paving the way for TriviumVet.

Established in 2015 and headquartered in Waterford, TriviumVet has a very specific focus – to bridge the key treatment gaps in companion animal health. The firm’s lead candidate is a treatment for gastric ulcer disease in dogs called OmepraVet (omeprazole). It has been designed to address a common complication of therapy with non-steroidal anti-inflammatory drugs (NSAIDs).
Ms Grubb explained gastric ulcers can be a significant problem in dogs that are on NSAIDs, with occurrence as high as 80% in certain cohorts. This is particularly an issue for dogs that are treated with NSAIDs on a long-term basis for diseases such as osteoarthritis – a common condition in an increasingly large and ageing dog population, and something that certain breeds can be predisposed to. NSAIDs are also used to manage chronic pain in dogs with cancer.

Ms Grubb said the current quality of care for gastric ulcers is far too low. Treatment to heal gastric ulceration is elevation of gastric pH but, at present, human gastric acid suppressants such as proton pump inhibitors (PPIs) are the only available therapies for veterinary treatment and are used off-label for dogs. This is despite a long-recognized need for a veterinary
PPI that is safer and more effective for companion animals. In fact, an American College of Veterinary Internal Medicine consensus statement published in 2018 noted not a single gastro-protectant agent is FDA-approved for dogs or cats. This also holds true in Europe.

In a randomized, blinded, two-way crossover study of healthy dogs, TriviumVet found OmepraVet significantly elevated gastric pH, compared to placebo. Moreover, intragastric pH was maximally increased on day two of treatment, indicating rapid action of the product. TriviumVet’s second lead product advancing in parallel with OmepraVet is the IntegralVet diagnostic for gastric ulceration and disease of the intestinal tract.

Ms Grubb told IHS Markit Animal Health: “IntegralVet is focused around the area of intestinal permeability. We wanted to look if there was a way to develop a point-of-care diagnostic for gastric ulcers. At the moment, a combination of invasive or elaborate tests are the usual method of diagnosis. IntegralVet will be definitive.” IntegralVet is a blood test – developed using a compound that would not normally be absorbed by the gut – designed to measure specific biomarkers, to not only assess gastrointestinal permeability but also pinpoint where in the gut abnormalities are present.
Ms Grubb explained the diagnostic technology also has the potential to be expanded to other health issues. She commented: “We’ll look to build on this in time but it could possibly be used in other areas such as chronic wasting disease and even cancer.” With its diagnostic, TriviumVet is well-positioned to address a significant unmet need both on a specific and broader level.
Ms Grubb explained gastric ulcer disease is currently an issue across approximately 5% of all dogs. GI disorders as a more general area of health – including protein-losing enteropathy and inflammatory bowel disease – can also benefit from early intervention using the same biomarker technology and represent an even bigger addressable market.

Wider pipeline
TriviumVet is also focusing on targeting cardiac disease in both cats and dogs. The company is developing Felycin for feline cardiomyopathy and RapaVet to target canine cardiac disease. Both are delayed-release veterinary formulations of rapamycin – a drug commonly used in human medicine. TriviumVet currently has four clinical studies of its cardiac candidates underway in cats and dogs.
A clinical trial in client-owned cats to evaluate the effectiveness Felycin in treating hypertrophic cardiomyopathy (HCM) was launched in January this year. Early data is expected in the coming months, which will also inform the design of future pivotal studies. Ms Grubb noted HCM affects roughly 15% of all cats and up to 29% of older cats, but current treatment is geared towards tackling symptoms rather than the disease itself. However, according to TriviumVet, previous laboratory animal studies and effects observed in human organ transplant
patients suggest rapamycin could potentially slow disease progression or reverse the adverse cardiac remodelling underlying the disease process in HCM. This means Felycin could be a game changer. TriviumVet has already seen positive signs in preclinical investigations, which showed repeated dosing of Felycin was well tolerated by healthy cats, at multiples of the intended therapeutic dose. Additionally, the US FDA’s Center for Veterinary Medicine (CVM) recently confirmed the firm’s program for the development of Felycin in treating HCM is eligible to pursue
the expanded conditional approval pathway in the US – moving the candidate a step closer to full approval and commercialization.

TriviumVet said in granting Felycin eligibility to pursue conditional approval, the CVM acknowledges there is currently no animal drug approved in the US for the treatment of feline HCM.
Ms Grubb stated: “We are very pleased with this positive response from CVM as it establishes a pathway to first conditional and then full approval, potentially expediting access to the drug for millions of at-risk patients. We are excited to share results of our clinical work early next year and intend to submit our final study report to the CVM once these results are available. At TriviumVet we strive to produce treatments for clinical unmet needs and feline HCM is one of the diseases that must urgently be addressed.” On the canine side, TriviumVet is working on developing RapaVet to target dilated cardiomyopathy and mitral valve disease in dogs. As with Felycin, RapaVet is currently in the pilot study phase, although the canine program is at a slightly
earlier stage than its feline counterpart.

Notably, TriviumVet’s R&D is playing a bigger role in the pet health research space. RapaVet is an example of this – the candidate is part of the business’ collaboration with the Dog Aging Project in the US. The Dog Aging Project brings together a network of dogs, owners, veterinarians and researchers in what it claims is the “most ambitious canine health study in the world”. The National Institutes of Health-funded initiative will follow tens of thousands of companion dogs for 10 years to identify the biological and environmental factors that maximise healthy longevity. As part of the project, a subset of participating dogs will be selected to be part of the Test of Rapamycin in Aging Dogs (TRIAD) trial, which is aimed at exploring the potential of the drug to improve health span and will use the RapaVet formulation. The Dog Aging Project and TriviumVet are both set to gain new data that will improve the understanding of the potential of rapamycin for both treatment of disease and long-term age-related benefits.

Elsewhere in its pipeline, TriviumVet is advancing its TRIV209-L candidate for chronic kidney disease (CKD) in cats. Proofof-concept studies have been established and safety trials are expected to begin towards the end of 2021. Ms Grubb pointed out there is a high incidence of CKD among cats, with very few treatment options available. She commented: “We should have a treatment that should reverse some of the disease progression of CKD and we expect to see remodelling of some of the damage to nephrons that occurs.” TriviumVet is also working on a therapy for neuropathic pain in dogs called Syrandol. This candidate is in the very early phases of development – the formulation has been developed and TriviumVet is now looking at GMP manufacturing
scale-up.

Road to commercialization
TriviumVet has a broad pipeline that is primed for meeting the therapeutic and diagnostic gaps in pet health, with the potential for disease modification among its candidates – a sought after factor in therapeutic development. The business previously closed a seed round of €3.2 million ($3.8 million) in 2018. Later on in March 2020, despite the COVID-19 pandemic being in full-swing, TriviumVet managed to finalize a series A round of €5.1m. In the face of high uncertainty and turbulence amid the crisis, this reflected a strong level of investor confidence in the company’s pipeline.

Ultimately, TriviumVet plans to license or offload its candidates to bigger entities once they are at the commercial stage. The firm is in good stead to partner with the bigger animal health players, who are increasingly looking to populate their pipelines with novel innovations – that have the potential to independently be game-changing therapies or augment
existing in-house R&D – in both therapeutic and diagnostic areas.

Ms Grubb told IHS Markit Animal Health: “We’ve been well funded to date and we’re now in discussions with commercialization partners. Our first launches will be in the US and our initial partners will have a presence there. You can see with the big companies they’re hungry for new products. With our combination of treatments alongside diagnostic technology, we’ve had a lot of interest. “As a young company that is R&D-focused, in some ways you are always waiting for something to happen. We’ve been building up over several years and it’s really exciting our work is now coming together and we will have two products to go to market by mid-next year.”

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