CAVS is a significant and devastating disease burden with limited understanding of the biology driving valvular calcification and disease progression.

Calcific aortic valve stenosis (CAVS) is a progressive disease characterized by calcification of the aortic valve and reduced blood flow from the heart. CAVS is the third most common cardiovascular condition in the U.S. and is known to lead to heart failure and death without intervention.

With no approved therapy to treat the cause of this progressive disease, people with CAVS are left to “watchful waiting” as the current standard of care until the condition advances to the severe stage which requires surgery. There is a critical unmet need for new therapies to treat the underlying cause of the disease and mitigate the need for valve replacement surgery, a challenge compounded by limited understanding of the biology driving valvular calcification and disease progression.

Kardigan is developing ataciguat, a once-daily, oral soluble guanylate cyclase activator, as a potential first-in-class treatment for people with moderate CAVS. Current standard of care for the treatment of CAVS is ‘watchful waiting’ until the disease progresses to advanced CAVS which requires valve replacement surgery. Ataciguat has the potential to revolutionize the management of CAVS as the first therapy to treat the underlying cause of the disease by targeting calcium as the driver of disease progression.

In a 6-month, Phase 2 clinical trial, treatment with ataciguat demonstrated over a 50% reduction in aortic valve calcium versus placebo, improved ventricular structure and function, and no observed effects on blood pressure, results that were consistent with preclinical evidence.

The ongoing KATALYST-AV clinical trial is currently enrolling patients and will evaluate the effect of ataciguat on slowing the progression of AVC and cardiopulmonary function. Learn more about KATALYST-AV here.

Kardigan acquired rights to ataciguat, an investigational drug developed by, and in-licensed from, Sanofi and Mayo Clinic.