Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MYK-491 · 1 trial · 2 indications
Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs).
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to the corresponding period.
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to first randomized dose.
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Number of participants with clinically significant laboratory abnormalities.
Number of participants with clinically significant physical examinations abnormalities.
| Arm | Type | Description |
|---|---|---|
| Part 1/SAD and Part 2/MAD - drug | OTHER | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
| Part 1/SAD and Part 2/MAD - placebo | OTHER | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
| Name | Type | Description |
|---|---|---|
| MYK-491 | DRUG | Single Ascending Dose and Multiple Ascending Dose of MYK-491 |
| Placebo | DRUG | Single Ascending Dose and Multiple Ascending Dose of placebo |
Key Inclusion Criteria: * Has stable chronic heart failure with reduced ejection fraction * Has adequate acoustic windows for echocardiography Key Exclusion Criteria: * Any significant structural cardiac abnormalities on Screening TTE * At Screening, symptomatic hypotension or hypertension or bra...
MYK-491 is an investigational small molecule being developed for the treatment of heart failure with reduced ejection fraction. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended to address conditions such as dilated cardiomyopathy, which is characterized by impaired heart function.
MYK-491 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety, tolerability, and preliminary pharmacokinetics and pharmacodynamics of this investigational drug in patients with heart failure.
MYK-491 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research to assess its safety and preliminary effects in patients with heart failure with reduced ejection fraction.
MYK-491 has one completed Phase 1 clinical trial registered under the identifier NCT03447990. This study evaluated the safety, tolerability, and preliminary pharmacokinetics and pharmacodynamics of MYK-491 in 52 participants with heart failure with reduced ejection fraction and dilated cardiomyopathy. The trial was conducted in multiple countries, including the United States, France, Germany, and the United Kingdom.
MYK-491 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed its safety and preliminary effects, but the drug has not yet received regulatory approval for the treatment of heart failure with reduced ejection fraction or any other condition.