Our current clinical trials are designed to target critical disease drivers.
Guided by our Cardiac Intelligence model, we prioritize the right targets and biomarkers, design adaptive clinical trials to identify the patients most likely to benefit, and measure effects on both the structure and function of the heart as well as the quality of life of patients.
Program
Ataciguat
Indication
Moderate Calcific Aortic Valve Stenosis
Study Name
KATALYST-AV
Phase/Status
Phase 3, Ongoing
KATALYST-AV is a two-part adaptive Phase 3 randomized, placebo-controlled clinical trial for adults 50 and older living with moderate calcific aortic valve stenosis (CAVS) investigating the effectiveness of ataciguat to slow the buildup of calcium in the aortic valve, slow the rate of aortic valve area loss, and affect peak oxygen consumption in adults with moderate CAVS compared to a placebo. It will also assess the safety and tolerability of ataciguat.
For more information about KATALYST-AV, visit NCT07001800. For patients interested in learning more, visit www.katalystavstudy.com.
Program
Danicamtiv
Indication
Genetic Dilated Cardiomyopathy
Study Name
KINSHIP-DCM
Phase/Status
Phase 2b/3, Planned
KINSHIP-DCM is a Phase 2b/3 adaptive, randomized, placebo-controlled study to assess the efficacy and safety of danicamtiv in people with genetic and familial dilated cardiomyopathy (DCM). It will include DCM patients with genetic variants in MYH7 or TTN genes, as well as those with familial DCM or DCM variants in other genes. The adaptive design means that the results from Part 1 of the study (Phase 2b) will inform the final design of Part 2 (Phase 3).
For more information about KINSHIP-DCM, visit NCT07210723.
Program
Tonlamarsen
Indication
Uncontrolled Hypertension
Study Name
KARDINAL
Phase/Status
Phase 2b, Enrollment Complete
KARDINAL is a Phase 2b randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of tonlamarsen in people with a history of uncontrolled hypertension who, despite being on stable antihypertensive therapy, have not achieved their target blood pressure. The trial was initiated to address an unmet need for effective blood pressure reduction strategies in this patient population and results will be used to inform future clinical trials.
The co-primary objectives are to evaluate the effect of tonlamarsen on plasma angiotensinogen levels and home systolic blood pressure through 20 weeks of treatment. For more information about KARDINAL, visit NCT06864104.
Expanded Access Policy
Consistent with Kardigan’s mission to develop targeted treatments for patients with cardiovascular diseases, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible.
At this time, Kardigan provides access to its investigational drug products, which have not been approved by FDA or other regulatory authorities, only through participation in clinical trials. Access to Kardigan’s investigational drug products for those not participating in Kardigan clinical trials is not currently possible. For more information about this policy, please contact [email protected]. More information about Kardigan’s clinical trials is available at www.clinicaltrials.gov.
Kardigan reserves the right to review and update this expanded access policy at any time.