Business Wire·Nov 6, 2026, 4:05 PM ET

Kardigan Completes Enrollment in Phase 2b KATALYST-AV Trial and Announces New Evidence Supporting Patient Selection and Endpoints for the Evaluation of Ataciguat in Aortic Stenosis

Kardigan, Inc. announced completion of enrollment in the Phase 2b KATALYST-AV trial of ataciguat for aortic stenosis.
The primary endpoint of aortic valve calcium will be assessed at Week 48 alongside measures of cardiac structure & function.
An internal interim analysis is planned for Week 24 to evaluate progression rates & mechanistic trends before Phase 3 design.
Topline data from the Week 48 assessment is expected in the second half of 2027.
Real-world analysis of approximately 45,000 patients identified baseline aortic valve area as the strongest predictor of rapid disease progression.
Approximately 27% of patients with mild-to-moderate aortic stenosis progressed rapidly, defined as a decline in aortic valve area of at least 0.1 cm² per year.
Patients with signs of cardiac damage, including left ventricular hypertrophy or low flow, were more likely to experience rapid progression & worse outcomes.
Baseline aortic valve calcium varied widely in the KATALYST-AV trial & real-world data, indicating it reflects risk but not the pace of progression.
The trial protocol was amended to extend the primary endpoint assessment duration to better capture the effect of ataciguat on valve calcification.
Kardigan will host an investor webcast on November 7, 2026, at 8:00 AM ET during the American Heart Association Scientific Sessions.