Kardigan Completes KATALYST-AV Enrollment and Moves Primary Assessment to Week 48
Kardigan says 156 participants are enrolled in the Phase 2b KATALYST-AV trial testing ataciguat in aortic stenosis. The company moved the primary aortic valve calcium assessment to Week 48, added cardiac structure and function measures, and plans an internal Week 24 analysis. Topline results are expected in 2H 2027, while a real-world analysis of approximately 45,000 patients found that about 27% met the study's rapid-progression definition.
Why it matters
The protocol change pushes the main efficacy readout to Week 48 and adds an interim look that may shape the Phase 3 design. Kardigan expects to update its Phase 3 plans in the first half of 2027 and report Week 48 topline data in the second half of 2027.
Key facts
- 1Kardigan enrolled 156 participants in the KATALYST-AV trial. sec.gov
- 2The primary aortic valve calcium endpoint will be assessed at Week 48, alongside measures of cardiac structure and function, with an internal interim analysis at Week 24. sec.gov
- 3Baseline aortic valve calcium among the first 139 participants ranged from 320 to 1,983 Agatston units. sec.gov
- 4The real-world analysis covered approximately 45,000 people with mild-to-moderate aortic stenosis. sec.gov
- 5Approximately 27% of patients met the rapid-progression definition, which required an aortic valve area decline of at least 0.1 cm²/year. sec.gov
- 6Kardigan expects to report Week 48 topline data in 2H 2027. sec.gov
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.