Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CK-3773274 · 1 trial · 1 indication
Participant incidence of reported AEs to determine the safety and tolerability of aficamten in participants with HCM.
Participant incidence of LVEF \< 50% as assessed by the core laboratory assessment.
Participant incidence of reported SAEs to determine the safety and tolerability of aficamten in participants with symptomatic HCM.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (oHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 1 (oHCM) - Placebo | PLACEBO_COMPARATOR | Participants received placebo once daily for up to 10 weeks |
| Cohort 2 (oHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses 10 - 30 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Cohort 2 (oHCM) - Placebo | PLACEBO_COMPARATOR | Participants received placebo once daily for up to 10 weeks |
| Cohort 3 (oHCM) - Aficamten & Background Disopyramide | EXPERIMENTAL | Participants received CK-3773274 doses 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks while taking disopyramide |
| Cohort 4 (nHCM) - Aficamten | EXPERIMENTAL | Participants received CK-3773274 doses of 5 - 15 mg once daily with dose levels guided by echocardiography assessments for up to 10 weeks |
| Name | Type | Description |
|---|---|---|
| CK-3773274 (5 - 15 mg) | DRUG | CK-3773274 tablets administered orally once daily |
| CK-3773274 (10 - 30 mg) | DRUG | CK-3773274 tablets administered orally once daily |
| Placebo for CK-3773274 | DRUG | Placebo administered orally once daily |
Inclusion Criteria * Males and females between 18 and 85 years of age at screening. * Body weight is ≥45 kg at screening. * Diagnosed with HCM per the following criteria: * Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease. * Has minimal ...
CK-3773274 is an investigational small molecule being developed for the treatment of hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle becomes thickened. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
CK-3773274 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CYTK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with hypertrophic cardiomyopathy.
CK-3773274 is in Phase 2 clinical development. A Phase 2 dose-finding study has been completed, evaluating the drug in adults with hypertrophic cardiomyopathy. The drug is investigational and not yet approved for commercial use.
CK-3773274 has one completed clinical trial, registered as NCT04219826. This Phase 2 study was a randomized, double-blind, placebo-controlled dose-finding trial that enrolled 96 adults with hypertrophic cardiomyopathy across the United States, Italy, Netherlands, and Spain.
CK-3773274 is a small molecule designed to target the underlying pathophysiology of hypertrophic cardiomyopathy. While the specific molecular target is not disclosed in available information, the drug is being studied for its effects on cardiac muscle function in patients with this condition.