Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Losmapimod twice daily · 1 trial · 1 indication
The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.
| Arm | Type | Description |
|---|---|---|
| Losmapimod | EXPERIMENTAL | Losmapimod 7.5 mg twice daily oral tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo twice daily oral tablet |
| Name | Type | Description |
|---|---|---|
| Losmapimod 7.5 mg twice daily | DRUG | Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets. |
| Placebo twice daily | DRUG | Subjects will receive placebo as film-coated, round, plain faced tablets. |
| Standard therapy | DRUG | Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy. |
Inclusion Criteria: * Signed written informed consent * Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy * Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI) * With the following timing of symptoms: NST...
Losmapimod is an investigational small molecule being studied for Acute Coronary Syndrome (ACS). It was evaluated in a Phase 3 clinical trial to compare the incidence of major adverse cardiovascular events in subjects presenting with ACS treated with losmapimod compared to placebo. The drug is not approved and remains in clinical development.
Losmapimod is a small molecule being developed for Acute Coronary Syndrome. Its specific molecular target is not disclosed in the available information. The drug was studied in a Phase 3 trial to assess its effect on major adverse cardiovascular events compared to placebo.
Losmapimod is being developed by GSK plc (ticker: GSK). The company conducted a Phase 3 clinical trial of losmapimod in Acute Coronary Syndrome, which has been completed.
Losmapimod is in Phase 3 clinical development for Acute Coronary Syndrome. It is an investigational drug and has not been approved. A Phase 3 trial, LATITUDE-TIMI 60, has been completed.
Losmapimod has one completed Phase 3 trial, NCT02145468, titled LATITUDE-TIMI 60. This randomized, double-blind, placebo-controlled study enrolled 3,503 participants with Acute Coronary Syndrome across multiple countries, including the United States, Argentina, Australia, and European nations.
No, Losmapimod is the drug being studied, while LATITUDE-TIMI 60 is the name of the Phase 3 clinical trial (NCT02145468) that evaluated losmapimod in Acute Coronary Syndrome. The trial compared losmapimod to placebo in 3,503 participants.