The trial, called Liberate, will take place in two acute care hospitals in the UK (the Queen Elizabeth Hospital in Birmingham and the Northern General Hospital in Sheffield) following the signing of a partnership between French company Acticor Biotech and the UK’s University of Birmingham.
The drug’s main focus to date has been in stroke patients: with the new trial representing an additional indication.
Avoiding significant heart damage
Acticor Biotech, a spin-off from INSERM (the French National Institute of Health and Medical Research), is developing the treatment for cardiovascular emergencies.
Glenzocimab (ACT017) is a humanized monoclonal antibody (mAb) fragment directed against a novel target of major interest, platelet glycoprotein VI (GPVI), for the treatment of cardiovascular emergencies. It stops the functioning of platelets that cause abnormal clotting of blood: targeting only dangerous clotting inside damaged blood vessels that can cause strokes and heart attacks.
Glenzocimab is already in a Phase 2/3 study for stroke patients, and the new trial will now see whether glenzocimab can reduce the amount of dead heart tissue in patients following an ST segment evaluation myocardial infraction (STEMI), the most serious type of heart attack.
Announcing the new partnership between Acticor Biotech and the University of Birmingham for the new trial, Professor Jon Townend, Consultant Cardiologist at University Hospitals Birmingham, Honorary Professor of Cardiology in the Institute of Cardiovascular Sciences at the University of Birmingham (and Chief Investigator of the trial) said: “We look forward to starting this exciting trial of a new drug for heart attacks which are still only too common. Although immediate opening of the blocked coronary artery by angioplasty in cases of heart attack is now routine, significant heart damage still occurs.
"Glenzocimab reduces clot formation and laboratory findings have been impressive. There are strong reasons to believe that this new drug may improve outcomes and this randomized blinded trial is the right way to test this theory.”
Dr Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, added: “This trial will help us establish whether glenzocimab is a safe and effective drug for preventing the kind of clotting that can lead to serious damage to the heart following a heart attack.
"We’re delighted to work with Acticor to see whether this new class of drug has the potential to improve the outcomes of our patients with heart attacks. While the immediate care provided for a heart attack is effective for improving patient survival, there is more we can do to prevent long-term damage to the heart.”
Stroke and COVID
In May, Acticor Biotech presented positive results from its Phase 1b/2a study, Actimis: confirming the safety profile and showing a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group in patients with stroke.
The efficacy of glenzocimab for stroke patients is currently being evaluated in an international Phase 2/3 study, Actisave, which will include 1,000 patients.
In July, Acticor Biotech was granted ‘Prime’ status by the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This designation will allow the company to strengthen its interactions and obtain early dialogues with regulatory authorities.
The drug was also assessed in a Phase 2 trial for acute respiratory distress syndrome (ARDS) in COVID patients, and although the safety data analysis confirmed good tolerability of the drug, no difference was shown for the primary efficacy endpoint of progression from moderate to severe respiratory distress between glenzocimab and placebo.