FULL DISCLOSURE: This is sponsored content for Cardiol Therapeutics.
Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) has reached a major milestone with the announcement that the first patient has been enrolled into a Phase III clinical trial for its lead drug candidate, CardiolRx™.
The trial, referred to as the Phase III MAVERIC trial by Cardiol, saw its first enrollment conducted by Northwestern University in Chicago. The study aims to evaluate CardiolRx™ for the prevention of recurrent pericarditis using a multi-center, randomized, double-blind, placebo-controlled trial. The trial aims to definitively assess the impact that CardiolRx™ has on the prevention of recurrent pericarditis in patients that are at high risk for relapse, and has been designed to support regulatory approval.
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The advancement to a Phase III trial follows Cardiol successfully completing a Phase II clinical trial in November, wherein CardiolRx™ was shown to result in marked and rapid reductions in both pericarditis pain and inflammation, which was maintained throughout the study. The Phase II trial also demonstrated a substantial reduction in the number of pericarditis episodes experienced by patients per year.
The Phase III trial is being conducted at cardiovascular clinical research sites across the US, Canada, and Europe, based on an Investigational New Drug Application that has been previously approved by the US FDA. An independent committee has been formed to lead the program, which includes a number of respected thought leaders on the topic of pericardial disease. The committee is said to include:
- Allan Klein, MD, CM from Cleveland Clinic (MAVERIC Program Chair);
- Massimo Imazio, MD, FESC from University of Udine, Italy (MAVERIC Program Co-Chair);
- Paul Cremer, MD from Northwestern University (MAVERIC Trial Principal Investigator);
- Allen Luis, MBBS, PhD from Mayo Clinic Rochester (MAvERIC-Pilot Principal Investigator);
- Antonio Abbate, MD, PhD from University of Virginia; and,
- Stephen Nicholls, MBBS, PhD from Monash University, Melbourne, Australia.
A total of 110 patients are expected to be enrolled in the MAVERIC trial. The study is specifically targeting patients that have been treated with an interleukin-1 blocker for at least twelve months, who’s use of the blocker is scheduled to be discontinued. CardiolRx™ or a placebo will be randomly assigned to these patients following the cessation of the blocker. Currently, up to 75% of patients that cease to use interleukin-1 blockers experience a recurrence in pericarditis within 12 weeks.
The primary objective of the trial is to assess the impact CardiolRx™ has versus placebo on freedom from a new episode of recurrent pericarditis at 24 weeks. Other clinical endpoints will also be measured, including time to a new episode of pericarditis recurrence, changes in pericarditis chest pain score, and changes to the C-reactive protein which is an inflammatory marker.
“Initiation of the MAVERIC Phase III trial is an important milestone in our Company’s efforts to provide a more accessible, non-immunosuppressive therapeutic option for thousands of pericarditis patients. [..] Based on the strength and consistency of the data from our Phase II MAvERIC-Pilot study, we believe that CardiolRx™ can make a meaningful difference in the lives of pericarditis patients,” commented David Elsley, CEO of Cardiol Therapeutics, on the achievement.
Cardiol Therapeutics last traded at $1.44 on the TSX.
FULL DISCLOSURE: Cardiol Therapeutics is a client of Canacom Group, the parent company of The Deep Dive. Canacom Group is long the equity of Cardiol Therapeutics. The author has been compensated to cover Cardiol Therapeutics on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.
