Clinical stage biotechnology company Acticor Biotech has recruited the first patient in Phase II GARDEN study of glenzocimab (ACT017) to treat Covid-19 related acute respiratory distress syndrome (ARDS).
Glenzocimab is a humanised Antibody Fragment (Fab) directed against platelet glycoprotein VI (GPVI) and inhibits its action.
The therapeutic candidate is proposed as a Covid-19 treatment to reduce the contribution of platelets to uncontrolled lung inflammation.
The randomised, double blind, multi-centre, placebo controlled, parallel group, exploratory study will analyse the efficacy and safety of glenzocimab in SARS-CoV-2-related ARDS.
For the study, the first patient has been enrolled in University Hospitals of Strasbourg and a total of 60 participants will be enrolled in France and Brazil.
Evaluating the effect of glenzocimab in preventing clinical progression of disease along with standard-of-care in Covid-19 patients with ARDS will form the study’s primary objective.
Acticor Biotech noted that glenzocimab might be a treatment option for Covid-19 related ARDS and might prevent downstream complications due to pro-thrombotic conditions.
Strasbourg University Hospital professor Julien Pottecher is the principal investigator of the study in France while Hospital Alemão Oswaldo Cruz professor Victor Sato will be the Brazilian study’s principal investigator.
Acticor Biotech CEO and founder Dr Gilles Avenard said: “We are very pleased to have received authorisations from the health authorities in France and Brazil, respectively ANSM and ANVISA, to launch our Phase II GARDEN study in Covid-19 related ARDS with glenzocimab.
“The scientific rationale to support the use of glenzocimab in this pathology is well established and our aim is now to demonstrate clinically its utility. We hope our product will soon help patients to fight against the disease.”
In 2018, Acticor Biotech reported positive results from Phase I clinical trial of ACT017 to treat acute phase of thrombotic diseases, including stroke and other thrombosis disorders such as pulmonary embolism.