- Approval of phase 2 GARDEN study in France and Brazil
- GARDEN will enroll 60 patients hospitalized for COVID19
- First Patient included at University Hospital of Strasbourg
Paris, December 22th, 2020 – Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including acute ischemic stroke, today announces the recruitment of the first patient of its phase 2 GARDEN study to treat COVID-19 _related acute respiratory distress syndrome (ARDS) with glenzocimab.
GARDEN (clinicaltrials.gov NCT04659109) is a phase 2 study, randomized, double blind, multicenter, placebo controlled, parallel group, exploratory efficacy and safety study of glenzocimab in sars-cov-2-related acute respiratory distress syndrome. GARDEN will enroll 60 patients in France and in Brazil. The Professor Julien POTTECHER, Strasbourg University Hospital, is the Principal Investigator of GARDEN in France. The Professor Victor A. Hamamoto SATO, Hospital Alemão Oswaldo Cruz in São Paulo, is the Principal Investigator of GARDEN in Brazil.
The first patient of the GARDEN study has been enrolled in University Hospitals of Strasbourg.
The primary objective of the study is to evaluate the effect of glenzocimab in preventing clinical progression of disease, when added to standard-of-care in COVID-19 patients presenting with acute respiratory distress syndrome. Glenzocimab might be an additional treatment option for COVID19 infected patients who present with ARDS. This treatment might also prevent downstream complications due to pro-thrombotic conditions.
“We are very pleased to have received authorizations from the health authorities in France and Brazil, respectively ANSM and ANVISA, to launch our phase 2 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. “ says Dr Gilles Avenard, CEO and founder of Acticor Biotech.
About glenzocimab (ACT017), the Therapeutic Candidate
Acticor is developing glenzocimab (ACT017), a humanized Antibody Fragment (Fab). The therapeutic candidate is directed against a novel target of major interest, platelet glycoprotein VI (GPVI), and inhibits its action. Evidence of antithrombotic efficacy of glenzocimab and safety of inhibition of GPVI have been established both ex vivo and in vivo. The target is involved in the growth of the thrombus, but not in physiological haemostasis. This limits the bleeding risk associated with its inhibition.
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Glenzocimab is being proposed as a treatment of severe acute respiratory syndrome (SARS) in COVID-19 infected patients (SARS-Cov-2) to limit the contribution of platelets to uncontrolled lung inflammation and prevent downstream complications due to pro-thrombotic conditions without inducing unwanted bleeding.
The primary objective of the GARDEN (clinicaltrials.gov NCT04659109) is to evaluate the effect of glenzocimab in preventing clinical progression of disease, when added to standard-of-care in COVID-19 patients presenting with ARDS.
About Acticor Biotech
Acticor Biotech is a clinical stage biotechnology company, spin-off of INSERM, dedicated to developing an innovative treatment in the therapy of acute thrombotic diseases, including ischemic stroke. Acticor Biotech is built upon the expertise and the results of research conducted by the founders: Dr. Martine Jandrot-Perrus at INSERM Paris and Pr. Philippe Billiald at Paris-Sud University.
Acticor Biotech is a partner in the BOOSTER consortium, dedicated to the management and new treatments of cerebrovascular accidents (CVA) in emergency situations.
Acticor Biotech is backed by a syndicate of European and International investors: Karista, Go Capital, Newton Biocapital, CMS Ventures, Mirae Asset Capital, Anaxago, Primer Capital & Armesa Foundation.
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