Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BAY1067197 (treatment 2)
BAY1067197 · 2 trials · 1 indication
Heart rate was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in heart rate were recorded and analysed.
Blood pressure was measured by monitor measurements after 30 minutes resting in a supine position. The relevant changes in blood pressure were recorded and analysed.
A complete standard 12-lead ECG was recorded and evaluated parameters such as heart rate, PR/PQinterval, QRSD interval, QT interval (uncorrected). Clinically relevant findings in ECG such as a second degree AV-block Mobitz type I (Wenkebach), Mobitz type II - or any third-degree AV block were recorded and reported. A 24-hour Holter ECG was recorded with a standard Holter ECG recorder for the purpose of detecting AV blocks, no higher degree AV blocks \> 1 or clinically relevant effect on HR were observed during Holter monitoring periods.
The change in LVEF between the post and the pre-treatment measurements were analyzed using Bayesian statistics to quantify the difference between BAY1067197 treatment and placebo measured by CMR. LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart.
Maximum observed BAY84-3174 concentration in plasma, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Maximum observed drug concentration, directly taken from analytical data, divided by dose. Geometric mean and %CV were reported.
AUCtau is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
AUCtau/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval divided by dose after the first dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
Cmax,md is defined as maximum observed drug concentration in plasma after multiple-dose administrations during a dosing interval directly taken from analytical data.Geometric mean and %CV were reported.
Maximum observed drug concentration, directly taken from analytical data divided by dose after multiple doses. Geometric mean and %CV were reported.
AUCtau,md is defined as area under the plasma concentration time profile from time zero during the dosing interval after multiple-dose administrations and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
AUCtau,md/D is defined as area under the plasma concentration time profile from time zero to the end of the dosing interval after multiple dose of administrations divided by dose and dosing interval was 24 h for both arms. Geometric mean and %CV were reported.
| Arm | Type | Description |
|---|---|---|
| BAY1067197 (10 mg) | ACTIVE_COMPARATOR | - |
| BAY1067197 | ACTIVE_COMPARATOR | - |
| Placebo (10 mg) | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Placebo and BAY1067197 | EXPERIMENTAL | Patients will get both treatment 1 and 2 |
| Name | Type | Description |
|---|---|---|
| BAY1067197 (10 mg) | DRUG | 10 mg BAY1067197 for 7 d treatment once daily as oral application |
| BAY1067197 | DRUG | The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application. |
| Placebo (10 mg) | DRUG | 10 mg Placebo for 7 d treatment once daily as oral application |
| Placebo | DRUG | 5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application |
| Placebo (treatment 1) | DRUG | Oral administration of placebo tablets |
| BAY1067197 (treatment 2) | DRUG | Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197 |
* Inclusion Criteria: * Clinical diagnosis of chronic systolic heart failure of ischemic or non-ischemic etiology:(New York Heart Association)NYHA class I-III and treatment with standard pharmacological therapy for the treatment of systolic heart failure including β-blocker ≥ 4 weeks prior to random...
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BAY1067197 is an investigational small molecule being studied for the treatment of heart failure. It has been evaluated in Phase 2 clinical trials in patients with stable heart failure, including patients receiving standard therapy with a beta-blocker. It is not approved for any indication and remains in clinical development.
BAY1067197 targets ADORA1, the adenosine A1 receptor, and acts as an agonist at this receptor. This target class places it among compounds designed to modulate adenosine signaling in the cardiovascular system, which is the basis for its study in heart failure.
BAY1067197 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 2 heart failure studies of the compound.
BAY1067197 is in Phase 2 development. Both of its heart failure trials have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency for heart failure or any other indication.
BAY1067197 has been studied in two completed Phase 2 trials: NCT02040233, a multiple dose study in heart failure conducted in Germany, Italy, Netherlands, and Poland with 31 patients, and NCT01945606, which assessed safety in stable heart failure patients on standard therapy including a beta-blocker, run in the Netherlands with 11 patients.