Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as danicamtiv, BMS-986434
MYK-491 · 3 trials · 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 |
|---|---|---|
| Danicamtiv + Midazolam | EXPERIMENTAL | - |
| 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 |
| Single oral dose of MYK-491 | EXPERIMENTAL | single-dose, oral suspension |
| Single oral dose of placebo | PLACEBO_COMPARATOR | single-dose, oral suspension |
| Name | Type | Description |
|---|---|---|
| Danicamtiv | DRUG | Specified dose on specified days |
| Midazolam | DRUG | Specified dose on specified days |
| MYK-491 | DRUG | Single Ascending Dose and Multiple Ascending Dose of MYK-491 |
| Placebo | DRUG | Single Ascending Dose and Multiple Ascending Dose of placebo |
| MYK-491 or placebo | DRUG | Oral suspension |
Inclusion Criteria: * Ambulatory participants with stable HFrEF due to any etiology. * Body mass index (BMI) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive. * Documented left ventricular ejection fraction (LVEF) 15% to 45% (on 2 occasions), including at least once during Screenin...
MYK-491 is an investigational small molecule being developed for dilated cardiomyopathy and heart failure with reduced ejection fraction. It is a Phase 1 candidate and has not been approved for any indication. Bristol-Myers Squibb Company (BMY) is the developer. Clinical work so far has focused on safety, tolerability, pharmacokinetics and pharmacodynamics in these cardiovascular conditions.
MYK-491 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company holds the asset and has sponsored the clinical studies conducted to date. No other developer or partnership is associated with MYK-491 in the available program information.
MYK-491 is in Phase 1 clinical development. It is an investigational small molecule and is not approved for marketing in any country. The program has completed its Phase 1 studies, and no active trials are currently listed. Further development would be required before any regulatory submission could be considered.
Two completed Phase 1 trials have evaluated MYK-491. NCT03062956 was a single ascending dose study assessing safety, tolerability, pharmacokinetics and pharmacodynamics in 64 healthy volunteers in Australia. NCT03447990 was a randomized, double-blind, placebo-controlled study of 52 patients with heart failure with reduced ejection fraction or dilated cardiomyopathy, run across the United States, France, Germany, the Netherlands, Poland, Sweden and the United Kingdom.
No. MYK-491 is an investigational drug in Phase 1 development and has not received FDA approval. Both listed studies are early-stage Phase 1 trials focused on safety, tolerability, pharmacokinetics and pharmacodynamics rather than pivotal efficacy endpoints. Approval would require substantially later-stage clinical testing that has not been reported for this asset.
Across the two completed Phase 1 trials, 116 participants have been enrolled in MYK-491 studies. NCT03062956 enrolled 64 healthy volunteers, and NCT03447990 enrolled 52 patients with heart failure with reduced ejection fraction or dilated cardiomyopathy. The patient study was randomized, double-blind and placebo-controlled, and participants were at least 18 years of age.