Athera reached the targeted number of STEMI patients in the Phase 2 trial

Stockholm April 2, 2020 Athera Biotechnologies AB, a Swedish biopharmaceutical developer of therapeutic antibodies, announced that the last patient has been dosed in their Phase 2 study with ATH3G10, a new candidate drug for prevention of heart failure. The study completed recruitment by including 82 patients with STEMI and aims for top-line results to be presented in 2020, in accordance with earlier plans.

The target of the study with ATH3G10 was to include approximately 80 patients with acute myocardial infarction and high risk to develop heart failure. Treatment effect is measured by Magnetic Resonance Imaging (MRI) scans that correlate with development of heart failure. A total of 15 hospitals in Sweden, Denmark and The Netherlands have enabled the full recruitment of the study in a remarkably rapid and efficient way. The proof-of-concept study randomized acute MI patients to one dose of either ATH3G10 or placebo, immediately after the standard of care catheter intervention at acute cardiology units in hospital. The study was started in 2019 with the first patient recruited in April. Despite current challenges within the health care systems following the Corona-virus outbreak, study recruitment has now been completed according to plan and 82 patients have entered the trial. The study protocol will proceed into the follow-up period, where patients come back for a second MRI-imaging and for regular safety check-up. The study is designed to show if treatment with ATH3G10 significantly decreases the probability for heart failure following myocardial infarction, compared to placebo.

“We are very grateful that we were able to complete recruitment of patients to the study according to our plans,” says James Hall, CEO of Athera. “We owe the teams at the acute cardiology units and at the MRI units great respect for their outstanding dedication and active conduct in the study. This has been one of the quickest trials to recruit in this patient population in recent years. We continue to rely heavily on the involvement of the teams and participating patients throughout the follow-up period, despite the extraordinary challenges of the ongoing Covid-19 outbreak”.

About ATH3G10

ATH3G10 is a first-in-class fully human antibody to target phosphorylcholine (PC), the head group of oxidized phospholipids (oxPLs), an epitope on damaged or stressed cells. The candidate is initially being developed for patients with a large ST-elevation myocardial infarction who are at high risk of heart failure. Tissue from infarcted myocardium that has suffered an injury has large amounts of exposed PC, indicating that the body is not clearing away damaged cells effectively. Nonresolving inflammation can lead to cardiac remodelling and heart failure within months. The 5-year mortality in heart failure is 50%—worse than many cancers.