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
Key Highlights
- ➤Kardigan completes enrollment in 156-patient Phase 2b KATALYST-AV trial
- ➤Week 48 primary endpoint will assess aortic valve calcium alongside cardiac measures
- ➤Topline KATALYST-AV data expected in the second half of 2027
- ➤Real-world analysis found 27% of approximately 45,000 patients progressed rapidly
- ➤Baseline aortic valve area was the strongest predictor of aortic stenosis progression
Expert Statements
Tassos Gianakakos, Co-founder, chief executive officer and board chair of Kardigan
“Completing enrollment in KATALYST-AV is a foundational milestone for our program and an important one for people with aortic stenosis”
Tassos Gianakakos, Co-founder, chief executive officer and board chair of Kardigan
“As with our other clinical programs, KATALYST-AV was specifically designed to enable us to learn and adapt as evidence accumulates.”
Tassos Gianakakos, Co-founder, chief executive officer and board chair of Kardigan
“The real-world data give us a clearer picture of which AS patients progress more quickly to worsening outcomes and the markers associated with that progression, directly informing how we design our upcoming registrational trial.”
Tassos Gianakakos, Co-founder, chief executive officer and board chair of Kardigan
“In addition, our analysis of aortic valve calcium in the KATALYST-AV baseline data is consistent with the variability observed in the real-world data, which indicates more time is needed to assess a robust reduction in calcium with ataciguat versus placebo.”
Tassos Gianakakos, Co-founder, chief executive officer and board chair of Kardigan
“Together, these findings reinforce our development strategy addressing both valve calcification and ventricular dysfunction with ataciguat and strengthen our confidence in its potential to become the first therapy to slow the progression of aortic stenosis.”
Philippe Pibarot, DVM, PhD, FAHA, head of cardiology research, Université Laval
“These data add to the growing body of evidence that mild-to-moderate aortic stenosis is a continuum, with valvular disease and cardiac remodeling evolving at different rates across patients.”
Philippe Pibarot, DVM, PhD, FAHA, head of cardiology research, Université Laval
“Assessing changes in valve calcium over a longer period, alongside measures of disease progression, will provide a more complete picture of how changes in the valve relate to the course of the disease and outcomes that matter to patients.”
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
Primary endpoint of aortic valve calcium in KATALYST-AV to be assessed at Week 48 alongside aortic valve area and measures of cardiac structure and function; topline data expected 2H 2027
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