FDA's Centre for Veterinary Medicine deems TriviumVet's feline HCM program eligible for expanded conditional approval pathway

WATERFORD, Ireland, Sept. 16, 2021 /CNW/ -- TriviumVettm, an animal health research and development company focused on addressing unmet needs in companion animal medicine, today announced that the Food and Drug Administration's Centre for Veterinary Medicine has determined that the company can pursue the expanded conditional approval pathway for its feline hypertrophic cardiomyopathy (HCM) therapeutic candidate, Felycintm.

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 and while completing the pivotal clinical studies.

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. HCM is a serious and life-threatening condition that affects approximately 15% of cats.

Felycintm product development

TriviumVettm is conducting a clinical study in client-owned cats to evaluate the effectiveness of its patented, delayed-release rapamycin formulation (Felycintm) in treating HCM. Results of previous laboratory animal studies and effects observed in human organ transplant patients suggest that Felycintm 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 Felycintm to be well tolerated by healthy cats, at multiples of the intended therapeutic dose.

CEO Louise Grubb comments:

"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 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. The interest in this treatment was highlighted in our December 2020 survey of US veterinarians carried out by Brakke Animal Health where 80% of respondents were likely to prescribe a novel product to their HCM patients."

Hypertrophic Cardiomyopathy

For information on HCM in cats and further details of the TriviumVet Feline HCM study please visit the TriviumVet website. https://bit.ly/3zeJXmp

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. TriviumVet identifies gaps in available treatments and has developed a disruptive and differentiated portfolio with potential to transform existing standards of care in the speciality companion animal markets including cardiology, renal (CKD), neuropathic pain and gastrointestinal disease. You can read more about the TriviumVet pipeline here: https://triviumvet.com/pipeline/.

@triviumvet

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SOURCE TriviumVet