Acticor Biotech Announces the Completion of Enrollment in its GARDEN Clinical Trial, a COVID-19-induced Acute Respiratory Distress Syndrome Efficacy Study

Acticor Biotech, a clinical stage biotechnology company developing an innovative drug for the acute phase of ischemic stroke and thrombotic diseases, today announces the completion of recruitment in GARDEN, its phase 2 clinical study on the use of glenzocimab, a novel humanized monoclonal antibody fragment, in patients with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS).

GARDEN (NCT04659109) 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 Alemão 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," saysDoctor Victor A. Hamamoto SATO, Brazilian coordinating investigator for the GARDEN trial, nephrology department, Alemão 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 (DSMB) for this trial.

About therapeutic candidate glenzocimab (ACT017) 

Acticor Biotech is developing glenzocimab (ACT017), a humanized monoclonal antibody fragment (Fab). This therapeutic candidate is directed against a novel target of major interest, platelet glycoprotein VI (GPVI), and inhibits its action. Evidence of the antithrombotic efficacy of glenzocimab and the safety of its inhibition of GPVI has been established both ex vivo and in vivo. This target is involved in growth of the thrombus but not in physiological hemostasis, which thus limits the bleeding risk associated with its inhibition.

About glenzocimab and Stroke

Glenzocimab is being currently assessed as an add-on to standard of care therapy for ischemic stroke. Acticor Biotech has recently announced the completion of patient enrolment in ACTIMIS (NCT03803007), a multinational, multicenter, randomized, double-blind, placebo-controlled, single-parallel, escalating dose phase 1b/2a safety and efficacy study of glenzocimab.

The primary objective of this trial, involving 160 patients randomized to either 1000mg glenzocimab or its matching placebo, is to assess the safety of glenzocimab as an add-on to thrombolysis alone or thrombolysis plus thrombectomy.

About Acticor Biotech

Acticor Biotech is a clinical stage biotechnology company, a spin-off of INSERM, dedicated to developing an innovative treatment for acute thrombotic diseases, including ischemic stroke. Acticor Biotech has been built on the expertise and research conducted by the co-founders: Dr. Martine Jandrot-Perrus at INSERM Paris and Prof. Philippe Billiald at Paris-Sud University.

Acticor Biotech is a partner in the BOOSTER consortium, dedicated to the management of, and new treatments for, cerebrovascular accidents 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, Mediolanum farmaceutici & Armesa Foundation.