Data simultaneously published in The Journal of the American College of Cardiology (JACC)

Results presented in late-breaking oral session showed danicamtiv was well tolerated with significant improvements in ventricular and atrial function in patients with genetic dilated cardiomyopathy (DCM)

Data supports the planned investigation of danicamtiv in patients with familial and genetic DCM

Kardigan, a heart health company modernizing cardiovascular drug development, today announced positive Phase 2a clinical trial data evaluating danicamtiv in patients with genetic dilated cardiomyopathy (DCM). These results, presented in a late-breaking oral session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025 and simultaneously published in The Journal of the American College of Cardiology (JACC), demonstrated danicamtiv treatment was associated with statistically significant improvements in left atrial function index and left ventricular ejection fraction in patients with genetic DCM driven by sarcomeric mutations.

“Dilated cardiomyopathy is a devastating and progressive disease with no available treatments that target its underlying causes. Left untreated, dilated cardiomyopathy presents a significant risk of disease progression to advanced stages of heart failure,” said Neal Lakdawala, M.D., Mass General Brigham Heart & Vascular Institute. “The positive Phase 2a results for danicamtiv showed clinically meaningful improvements in direct activation of both ventricular and atrial function in the MYH7 and TTN cohorts, a finding we believe to be unique to danicamtiv. These findings represent an important step forward in the development of a potential first-in-class targeted treatment for patients with familial and genetic dilated cardiomyopathy.”

In the clinical trial, patients received danicamtiv for two consecutive treatment periods of 5-8 days each. Danicamtiv demonstrated an absolute mean change from baseline in left ventricular ejection fraction (LVEF) at the end of treatment period 2 of 8.8% (p=0.001), 5.9% (p=0.005), and 4.4% (NS) in the MYH7 cohort (n=12), TTN cohort (n=14), and DCM of Other Causes cohort (n=15), respectively. Danicamtiv demonstrated an absolute mean change from baseline at the end of treatment period 2 in left ventricular global longitudinal strain (LVGLS) of 2.1% (p=0.008), 1.2% (NS), and 1.4% (NS) in the MYH7 cohort, TTN cohort, and Other Causes cohort, respectively. Absolute mean change from baseline in left atrial function index (LAFI) was 11.1 (p=0.006), 6.8 (NS), and 4.4 (p=0.026) in the MYH7 cohort, TTN cohort, and Other Causes cohort, respectively.

Danicamtiv was well tolerated and no drug-related adverse events (AEs) leading to discontinuation, serious AEs, death, or severe treatment-emergent AEs were reported during the study period.

“While dilated cardiomyopathy often presents with similar clinical features, there are multiple disease variations driven by diverse underlying causes. There is a critical unmet need in the DCM community to match the right treatment to the right patient, especially for those whose disease is caused primarily by mutations impacting sarcomeric function,” said Jay Edelberg, M.D., Ph.D., co-founder and chief medical officer at Kardigan. “At Kardigan, we are laser-focused on moving beyond symptomatic treatment toward functional cures and have curated a late-stage portfolio of targeted medicines designed to modify the underlying cause of multiple cardiovascular diseases. The data presented at HFSA supports our hypothesis that danicamtiv directly activates myosin and corrects the dysfunction resulting from sarcomeric mutations in DCM patients. These positive results pave the way for ongoing development of danicamtiv in an upcoming clinical trial, KINSHIP-DCM, which is planned to initiate later this year.”

The Phase 2a multi-center, baseline-controlled, open-label clinical trial included 41 patients with DCM due to genetic variants (MYH7 or TTN) or Other Causes. In the treatment periods (each lasting 5-8 days), patients received oral danicamtiv 25 mg twice daily during treatment period 1 and dose adjusted in treatment period 2 to either 10 mg or 50 mg twice daily based on change in systolic ejection time.

Danicamtiv is one of three late-stage investigational candidates that Kardigan is developing, in parallel, as part of its portfolio of targeted medicines designed to modify the underlying cause of various cardiovascular diseases. The company is also developing tonlamarsen¹, an angiotensinogen-targeted bridging therapy to interrupt the dangerous cycle of acute severe hypertension, and ataciguat², a once-daily, oral soluble guanylate cyclase (sGC) activator, as a potential first-in-class treatment for calcific aortic valve stenosis and alternative to “watchful waiting.”

¹ Kardigan in-licensed exclusive worldwide development and commercialization rights to tonlamarsen, an investigational drug discovered and developed by Ionis.

² Kardigan acquired rights to ataciguat, an investigational drug developed by, and in-licensed from, Sanofi and Mayo Clinic.

About Dilated Cardiomyopathy (DCM)

DCM is a common and serious disease affecting the heart’s main ventricular and atrial chambers, making it difficult to pump blood to the rest of the body, and presents a significant risk of disease progression to advanced stages of heart failure. DCM is estimated to occur in as many as one in every 250 people, yet there are limited therapies available to specifically reduce or reverse progression of the disease by targeting the pathophysiology of DCM. An important opportunity exists to transform the standard of care for this progressive disease and examine the critical disease drivers across various dilated cardiomyopathy subtypes.

About Danicamtiv

Danicamtiv is an investigational cardiac myosin activator targeting familial and genetic dilated cardiomyopathy (DCM) driven by sarcomeric mutations to restore cardiac function through direct activation in both the left atrium and left ventricle. KINSHIP-DCM is planned to begin this year to evaluate the safety and efficacy of danicamtiv as a potential first-in-class treatment for familial and genetic DCM. Kardigan in-licensed exclusive worldwide development and commercialization rights to danicamtiv, an investigational drug discovered at MyoKardia and further developed by Bristol Myers Squibb.

About Kardigan

Kardigan is a patient-driven heart health company that is modernizing cardiovascular drug development to deliver medicines that move patients beyond symptom management to functional cures. By matching critical disease drivers with treatment responders identified in clinical trials, Kardigan is developing a portfolio of medicines that modify the underlying cardiovascular disease pathophysiology to get patients closer to the cures they deserve. The company is based in South San Francisco, California and Princeton, New Jersey. To learn more, visit Kardigan.bio.

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