New Data from the Phase II ARCHER Trial Demonstrate CardiolRx(TM) Improves Heart Structure in Patients with Acute Myocarditis, Supporting Expansion Across Inflammatory Cardiac Conditions

Executive Summary

• Phase II ARCHER trial demonstrated a statistically significant reduction in left‑ventricular mass (−9.2 g, p=0.0117) and improvements across multiple cardiac MRI endpoints in patients treated with CardiolRx™ versus placebo.
• Safety profile was comparable to placebo; adverse‑event discontinuation rates were balanced.
• Results bolster the scientific rationale for the ongoing Phase III MAVERIC trial (recurrent pericarditis) and support further development of CardiolRx™ and next‑generation candidate CRD‑38 across inflammatory cardiac indications.

Key Details

• Trial Design: Randomized, double‑blind, placebo‑controlled, multi‑center Phase II study; 109 patients enrolled across the U.S., France, Brazil, and Israel.
• Primary Efficacy Findings:
• LV mass reduced from 130.3 g (placebo) to 121.1 g (active), Δ = −9.2 g (p=0.0117).
• Extracellular volume (ECV): 33.6 mL vs. 37.3 mL, Δ = −3.7 mL (p=0.0538).
• Intracellular volume (ICV): 85.6 mL vs. 91.2 mL, Δ = −5.6 mL (p=0.0928).
• Left atrial end‑systolic volume (LAESV): −8.1 mL (p=0.0376).
• LV end‑diastolic volume (LVEDV): −7.4 mL (p=0.0981).
• Patient Demographics: Mean age 39 years; 81 % male; >70 % reported prior viral‑like illness; 96 % hospitalized for index event; median hospital stay 5 days.
• Safety: Treatment‑emergent adverse events leading to discontinuation were equal between groups; serious adverse event rates balanced.
• Regulatory Context: CardiolRx™ holds U.S. FDA Orphan Drug Designation for recurrent pericarditis (MAVERIC program).
• Future Development: Positive ARCHER data provide proof‑of‑concept for broader inflammatory cardiac indications, including immune checkpoint inhibitor‑induced myocarditis and heart failure with preserved ejection fraction.
• Investor Call: Webcast & conference call scheduled for 8:30 a.m. EST on the day of release; dial‑in numbers provided; webcast archived for ~90 days.

Notable Quotes

• “The ARCHER results show that CardiolRx™ can drive meaningful structural recovery in the hearts of patients with acute myocarditis,” – Dr. Andrew Hamer, Chief Medical Officer & Head of R&D, Cardiol Therapeutics.
• “These findings reinforce our confidence in this innovative treatment strategy and support advancing the clinical development of CardiolRx™ across multiple inflammatory cardiac conditions,” – David Elsley, President & CEO, Cardiol Therapeutics.