Therapy Areas: Respiratory
Acticor Biotech Completes Enrollment in its GARDEN Clinical Trial, a COVID-19-induced Acute Respiratory Distress Syndrome Efficacy Study
23 July 2021 - - French clinical stage biotechnology company Acticor Biotech has completed 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, the company said.

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.

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.

Acticor Biotech is developing glenzocimab (ACT017), a humanized monoclonal antibody fragment. This therapeutic candidate is directed against a novel target of major interest, platelet glycoprotein VI, 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.

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.

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 and Armesa Foundation.