ARCHER Results Published: Strengthening the Scientific Foundation for Cardiol’s Pivotal Phase III MAVERIC Trial

Cardiol Therapeutics is pleased to share the publication of results from its Phase II ARCHER study in ESC Heart Failure, a leading journal of the European Society of Cardiology.

ARCHER evaluated CardiolRx™ in patients with acute myocarditis — an inflammatory disease of the heart muscle for which there is currently no approved disease-specific therapy. But beyond a single disease, ARCHER was designed to answer a broader and strategically important question: does CardiolRx™ meaningfully impact inflammation-driven structural damage in the human heart?

The results provide a clear and encouraging answer.

What ARCHER Was Designed to Demonstrate
ARCHER was not designed as a registration or outcomes trial. It was designed to determine if CardiolRx™ could impact inflammation-driven structural damage in the human heart using some of the most sensitive cardiac imaging tools available.

Specifically, the study sought to determine whether CardiolRx™ could impact myocardial inflammation and cardiac remodelling at the tissue level — the underlying processes that drive disease progression across inflammatory conditions of the heart muscle.

What the Study Demonstrated
In the study, treatment with CardiolRx™ was associated with a statistically significant reduction in left ventricular mass, less cardiac remodelling, and a strong safety and tolerability profile.

These findings are consistent with a reduction in myocardial inflammatory burden and structural stress on the heart. Left ventricular mass, in particular, is closely linked to myocardial edema and inflammation in myocarditis, and its reduction is widely regarded as a meaningful marker of tissue-level recovery.

Put simply, the ARCHER results show that CardiolRx™ is doing what it is designed to do: reduce inflammation in cardiac tissue.

Why This Matters Beyond Myocarditis
Myocarditis is only one manifestation of a broader category of disease. Pericarditis and myocarditis exist on the same inflammatory disease spectrum because they result from similar causes, affect adjacent structures of the heart, and can appear in mixed forms. They are also driven by overlapping biological processes including inflammation, edema, and fibrosis.

That’s why the biological signals from ARCHER are highly relevant and strengthen confidence in our ongoing pivotal Phase III MAVERIC trial in recurrent pericarditis – which is which is focused on delivering meaningful outcomes for patients with recurrent pericarditis.

The Strategic Importance of These Results
The ARCHER results and the broader peer-reviewed dissemination in ESC Heart Failure underscores CardiolRx™’s therapeutic potential and provides additional compelling clinical evidence that CardiolRx™ impacts the underlying biology of inflammatory heart disease.

That is exactly the biology that affects patients who are now being recruited with recurrent pericarditis into MAVERIC; a condition associated with a poor quality-of-life burden and a need for new therapeutic options.

This is how serious cardiovascular medicines are built — step by step, with sound mechanistic rationale, a validated target, and rigorous, clinical trials that measure meaningful outcomes to patients and clinicians.

Read the Full Study
The full peer-reviewed publication is available in ESC Heart Failure: https://academic.oup.com/eschf/advance-article/doi/10.1093/eschf/xvaf034/8427108.