July 22nd 2021 –Acticor Biotech (“Acticor“) issued an announcement, which is summarized as follows:
GARDEN is a multinational, multicenter, randomized, double-blind, placebo- controlled, parallel group, phase 2 trial evaluating the efficacy and the safety of 1000mg Glenzocimab, administered daily over three consecutive days.
“Platelets are recognized for their inflammatory role and as immune effector cells in the lungs. There is a true need for new treatment in acute lung injury. Glenzocimab as antiplatelet therapy may offer a useful adjunctive strategy to fight virus-induced diseases. We are proud to have kicked off this study in France despite complex sanitary and administrative conditions and I seize the opportunity to thank all healthcare professionals for their commitment in clinical research despite terrible conditions during the pandemic‘s spikes“ says Professor Julien POTTECHER, Global Coordinator for the GARDEN trial and Head of the Department of Anesthesia-Resuscitation & Peri-Operative Medicine at Hautepierre Hospital at Strasbourg University Hospitals in France.
“We are proud to have completed patient recruitment for phase 2 of the GARDEN trial using Glenzocimab in SARS-Cov-2-related ARDS. This novel antithrombotic treatment may offer a response to an urgent unmet medical need in COVID-19-induced ARDS in that it limits uncontrolled inflammation and prevents complications without causing bleeding. Brazil and the Alem?o Osvaldo Cruz Hospital in Sao Paulo particularly, have made a major contribution, despite difficult COVID-19 conditions. We thank all health professionals who dedicated themselves to the success of this study.“ says Doctor Victor A. Hamamoto SATO, Brazilian coordinating investigator for the GARDEN trial, nephrology department, Alem?o Oswaldo Cruz Hospital, Sao Paulo, Brazil.
The primary objective of GARDEN (Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome) is to evaluate the safety and efficacy of Glenzocimab in preventing clinical progression of the disease when added to standard of care in COVID-19 patients presenting with ARDS.
Two countries, France and Brazil, have actively participated in including a total of 62 evaluable patients for the GARDEN trial. Preliminary data suggest that Glenzocimab is safely tolerated in COVID-19 patients with ARDS, a finding confirmed by the Drug Safety Monitoring Board for this trial.
Further information can be found in the Acticor Biotech‘s Press Release：