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TriviumVet makes headway towards US approval of feline HCM therapy - S&P Global feature

We were absolutely delighted to be featured in S&P Global last week in an article written by Joseph Harvey. See the article covering this exciting business update below.

TriviumVet has completed all technical sections for conditional US FDA approval of a feline sub-clinical hypertrophic cardiomyopathy (HCM) therapeutic.

The Irish company said this is “a significant milestone for feline health”. The product targets early-stage HCM in cats, which is a significant unmet need in cardiovascular health for cats.

TriviumVet chief executive Louise Grubb told S&P Global Animal Health the firm expects to receive US conditional approval in March ahead of a launch in June. This would be TriviumVet’s first commercialized product. The business is currently working on its plan to bring the therapy to market.

TriviumVet pointed out HCM is the most common feline cardiac disease and affects up to 15% of cats. Sub-clinical HCM is the early and asymptomatic phase, which often progresses to severe complications. These include congestive heart failure, arterial thromboembolism or sudden death. The business noted there are currently no therapies approved to address the condition.

The therapeutic candidate is now subject to a pivotal trial – the HALT HCM study. This is currently running at over 20 investigator sites throughout the US. In 2023, TriviumVet successfully completed a study evaluating the product’s effects on left ventricular hypertrophy in cats with subclinical.

Ms Grubb remarked: “The completion of all technical sections marks a major achievement for TriviumVet and our research partners. Our therapeutic fills a long-standing gap in feline cardiovascular care, aligning perfectly with the growing demand for proactive health solutions. This milestone underscores our
commitment to delivering transformative solutions for pets and their families.”

Waterford-based TriviumVet noted cat health products are “emerging as a key growth area in the veterinary sector”. There are 5.8 million to 8.7 million cats in the US that are potentially affected by subclinical HCM – about 15% of the US cat population at the higher end of the estimate.

The firm said the HCM treatment market is underserved and “the increasing willingness of pet owners to invest in innovative treatments positions this product for strong market adoption”. TriviumVet suggested the product will be a first-in-class therapeutic and not only broadens the therapeutic landscape for
feline subclinical HCM “but also reinforces the availability of opportunities for innovation in companion animal health”.

TriviumVet is also developing a therapeutic for feline chronic kidney disease – another prominent health issue in cats. The firm is also conducting R&D in gastroenterology, age-related decline and pain management for companion animals. The company was founded in 2015.