Proof-of-Concept study in Heart Failure started with anti-inflammatory antibody

The first patient in a new Phase 2 study with Athera lead candidate has been enrolled. The study is planned to run at eleven hospitals and includes myocardial infarction patients with high risk to develop heart failure, who receive either a single dose of the antibody ATH3G10 or placebo.

“Heart Failure is a severe condition and the 5-year mortality in Heart Failure is worse than in several cancers.” says Professor Stefan James, Head of Cardiology at Uppsala University Hospital and Principal Investigator of the study. “Addressing inflammation following treatment for acute myocardial infarction in high risk patients could contribute to improved outcome.”

The company’s lead program with ATH3G10 is a Proof-of-Concept study for high risk myocardial infarction patients. The study has received relevant approvals from national Medical Product Agencies and Ethical Review Boards. The primary endpoint is left ventricular expansion (measured by MRI imaging), a surrogate measure strongly linked to Heart Failure development. Other efficacy measures, as well as safety and tolerability will be assessed, and data is planned to report next year.

“We are excited over the start of this important study, where we aim to generate Proof-of-Concept data for ATH3G10” says Chairman Gunnar Olsson. “Treating inflammation is the next big breakthrough in fighting cardiovascular disease and our therapeutic antibody is a first-in-class candidate.”

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About ATH3G10

ATH3G10 is a fully human monoclonal antibody that binds to oxidized phospholipid, OxPL. The target is exposed on modified or damaged cells where membranes have been disrupted, or on oxidized lipid particles. Exposed OxPL is an” eat me”-signal for the immune system to clear out the damaged cells and acts pro-inflammatory. Three Phase 1 studies with ATH3G10 has previously reported positive data with both single and repeated dosing in healthy subjects and patients. A study to assess the effects of longer treatment on arterial inflammation in individuals with very high levels of Lp(a), a plasma lipoprotein with high capacity to carry the pro-inflammatory target, was run 2017-2018. One conclusion from the study was that subcutaneous dosing is advocated for repeated dosing with individuals with high Lp(a). This development strategy is now pursued by Athera in chronic conditions, while the intravenous formulation is used for short term treatments.