FDA’s Center for Veterinary Medicine deems TriviumVet’s feline HCM program eligible for expanded conditional approval pathway
TriviumVet™ are delighted to announce that the Food and Drug Administration’s Center for Veterinary Medicine has determined that our feline hypertrophic cardiomyopathy (HCM) therapeutic candidate, Felycin™ can pursue the expanded conditional approval pathway.
US Congress granted the FDA a limited expansion of the conditional approval pathway for certain new animal drugs under the 2018 reauthorization of the FDA’s Animal Drug User Fee Act (ADUFA) program. Conditional approval enables drug sponsors to legally market a product after demonstrating the drug is safe, manufactured in accordance with rigorous standards, and there is a reasonable expectation of effectiveness for use.
In granting eligibility to pursue conditional approval, CVM acknowledges that there is currently no animal drug approved in the US for the treatment of feline HCM. The condition is a serious and life-threatening condition that affects approximately 15% of cats.
Felycin™ product development
TriviumVet™ is conducting a clinical study in client-owned cats to evaluate the effectiveness of its patented, delayed-release rapamycin formulation (Felycin™) in treating HCM. Results of previous laboratory animal studies and effects observed in human organ transplant patients suggest that Felycin™ 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 Felycin™ 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.
CEO Louise Grubb comments “At TriviumVet we strive to produce treatments for clinical unmet needs and feline HCM is one of the diseases that must urgently be addressed.” In a December 2020 survey of over 250 US veterinarians carried out by Brakke Animal Health, 80% of respondents were likely to prescribe a novel product to their HCM patients, illustrating the desire by the veterinary community for new, first-in-disease treatments. Grubb goes on to comment “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 in client-owned cats in 2022 and intend to submit our final study report to CVM once these results are available”
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. 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 “I am delighted to see our industry availing of the expanded conditional approval pathway as it allows for new life-saving and life-changing treatments to be made available earlier in the development process. Our entire team together with our incredible research partners welcome this decision by CVM. We are focused on expediting development of this product and providing CVM with the data package required to support conditional approval.”
HCM Clinical trial
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 remain under the care of a specialist cardiologist throughout the duration of the study and are thoroughly evaluated at several points to detect treatment effects. The study is nearing complete recruitment, and the results will inform design of future pivotal studies. Should Felycin™ prove to be effective in treating adverse cardiac remodelling, it will offer veterinarians and cat owners a much-needed treatment option for this currently intractable condition.
 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.