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Cardiol Therapeutics to Advance CardiolRx(TM) into a Late-Stage Trial in Patients with Recurrent Pericarditis
MAVERIC-2 trial will evaluate the impact of CardiolRx(TM) following cessation of interleukin-1 bl...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics to Advance CardiolRx(TM) into a Late-Stage Trial in Patients with Recurrent PericarditisMAVERIC-2 trial will evaluate the impact of CardiolRx(TM) following cessation of interleukin-1 blocker therapy (rilonacept or anakinra) and is expected to run concurrently with the Company's planned Phase III program.Toronto, Ontario--(Newsfile Corp. - October 22, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (\"Cardiol\" or the \"Company\"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced plans to expand the MAVERIC clinical development program and advance CardiolRx™ into a late-stage clinical trial (\"MAVERIC-2\") to evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 (\"IL-1\") blocker therapy. MAVERIC-2 is expected to be initiated during Q4 at major pericardial disease centres in the United States and Europe and to report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis. \"MAVERIC-2 provides an exciting opportunity to expand the market potential for CardiolRx through the execution of a cost-effective study and potentially provides a path for an accelerated regulatory approval timeline,\" said David Elsley, President & CEO of Cardiol Therapeutics. \"This important new study, designed in collaboration with an international panel of advisors comprised of experts in pericarditis, will also augment data from our planned Phase III MAVERIC-3 trial by exploring the potential for our lead oral drug candidate to assist the growing number of recurrent pericarditis patients who seek alternative options to chronic use of immunosuppressant biologics.\"MAVERIC-2 is a randomized, double-blind, placebo-controlled Phase II/III trial in approximately 110 patients. Patients with stable disease who are receiving IL-1 blocker treatment will be randomly assigned to receive either CardiolRx™ or placebo following cessation of the IL-1 blocker. The primary clinical objective of the trial will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis. Other clinical endpoints of interest include time to a new episode ...