Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

Athera Biotechnologies

Status and phase: Completed; Phase 2

Conditions: ST Elevation Myocardial Infarction

Treatments: Drug: Placebo; Drug: ATH3G10

Study type: Interventional

Funder types: Industry

Identifiers

NCT03991143

2018-003676-12 (EudraCT Number)

ATH3G10-006

Details and patient eligibility

About

Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.

This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.

Enrollment: 82 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
• Start of PCI less than 4 hours after symptom onset.

Exclusion criteria

• Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
• Previous major vascular intervention within the last 4 weeks.
• History of an infarct in the same artery that is currently affected.
• Conditions contraindicating MRI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups, including a placebo group

ATH3G10

Experimental group

Description:

Phosphorylcholine human monoclonal antibody (ATH3G10)

Treatment:

Drug: ATH3G10

Placebo

Placebo Comparator group

Description:

Placebo to ATH3G10, 0.9% sodium chloride

Treatment:

Drug: Placebo