TriviumVet commence clinical study of first-in-disease treatment for HCM in cats
We are delighted to announce the initiation of a ground-breaking clinical study in client-owned cats to evaluate the effectiveness of our patented delayed-release rapamycin formulation (TRIV-203F) in treating hypertrophic cardiomyopathy (HCM).
Rapamycin background
Results of previous laboratory animal studies and effects observed in human organ transplant patients suggest that TRIV-203F has the potential to slow or reverse the adverse cardiac remodelling underlying the disease process in HCM. Preclinical investigations conducted by TriviumVet have shown repeated dosing with TRIV-203F to be well tolerated by healthy cats, at multiples of the intended therapeutic dose. The product’s pharmacokinetic behaviour has been characterized following single and multiple doses, and in addition to general observations and standard clinical pathology, treated cats have been evaluated for specific adverse effects reported in human patients.
Addressing unmet clinical needs
CEO Louise Grubb comments “At TriviumVet we strive to produce treatments for unmet clinical needs and HCM in cats is one of the diseases that veterinarians most urgently need to be addressed”
In a December 2020 survey of over 250 US veterinarians, carried out by Brakke Animal Health on behalf of TriviumVet, found that 80% of vets were likely to prescribe the TriviumVet HCM product to their patients, illustrating the recognition by the veterinary community of the need for new, first-in-disease treatments.
HCM in cats
Cardiomyopathies are common in cats, and cardiovascular disease is one of the leading causes of mortality in this species. The most common cardiomyopathy is HCM, with an estimated prevalence of approximately 15% in the general cat population, while up to 29% of older cats may be affected. Congestive heart failure (CHF) is the most common cause of clinical signs in cats with HCM, followed by arterial thromboembolism (ATE). A minority of cats die suddenly without prior clinical signs.1 Although treatments are available (largely unapproved for use in cats) for symptoms of CHF and ATE, a drug that targets the causative HCM has not yet been identified. TriviumVet CTO and veterinarian Stuart Fitzgerald comments “Watchful waiting is the usual approach adopted by clinicians having identified HCM in asymptomatic feline patients; a great demand exists from many millions of cats and their owners for an effective therapy. This is why we are so excited to see the results of this clinical trial.”
Study partners – UC Davis and NC State Universities
In partnership with renowned veterinary cardiologists at North Carolina State University and University of California, Davis, TriviumVet is recruiting cats with echocardiographic evidence of HCM for a 6-month placebo-controlled treatment trial at these two university centres. Enrolled cats will remain under the care of a specialist cardiologist throughout the duration of the study and will be thoroughly evaluated at several points to detect treatment effects. The study is expected to complete in late 2021, and the results will inform design of future pivotal studies in consultation with global regulatory authorities. Should TRIV-203F prove to be effective in treating adverse cardiac remodelling, it would offer veterinarians and cat owners a much-needed treatment option for this currently intractable condition. Dr Kathryn Meurs, DVM, PhD, DACVIM (Cardiology), Associate Dean for Research and Graduate Studies at NC State College of Veterinary Medicine has pioneered much of the work to date on feline HCM, and says “we are delighted to be part of this exciting study to develop a new treatment option for cats with this terrible disease.”
Further details on the study and contact details for the respective centres can be viewed at
UC Davis
And NC State
triviumvet.com/…/NC-State-HCM-Clinical-Study-Recruitment-Flyer.pdf
1 Luis Fuentes, V., Abbott, J., Chetboul, V., Côté, E., Fox, P. R., Häggström, J., … & Stern, J. A. (2020). ACVIM consensus statement guidelines for the classification, diagnosis, and management of cardiomyopathies in cats. Journal of Veterinary Internal Medicine.
TriviumVet Feline HCM study press release FINAL