Clinical TrialNov 6, 2026, 04:17 PM
Kardigan Completes Enrollment in Aortic Stenosis Trial; Data Expected 2H 2027
AI Summary
Kardigan, Inc. announced the completion of enrollment in its Phase 2b KATALYST-AV trial for ataciguat in patients with aortic stenosis. The primary endpoint, aortic valve calcium, will now be assessed at Week 48, with topline data anticipated in the second half of 2027. This adjustment follows analyses of baseline data and real-world evidence suggesting a longer assessment period is needed for robust results. The company will host an investor webcast to discuss these findings.
Key Highlights
- Kardigan completed enrollment in Phase 2b KATALYST-AV trial for ataciguat in aortic stenosis.
- Primary endpoint (aortic valve calcium) to be assessed at Week 48, with topline data expected in 2H 2027.
- Protocol amended to extend assessment of aortic valve calcium to Week 48 due to variability.
- Real-world analysis of ~45,000 patients supports patient selection and endpoints for Phase 3.
- Internal interim analysis at Week 24 to inform Phase 3 trial design.
- Company to host investor webcast on November 7, 2026, at 8:00 AM ET.
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