In response to the global COVID-19 pandemic, Acticor Biotech proposed using glenzocimab to treat acute respiratory distress syndrome (ARDS) in SARS-Cov-2 infected patients, in the context of a phase 2 clinical study (GARDEN NCT04659109).
The scientific rationale was to limit the contribution of platelets to uncontrolled pulmonary inflammation and prevent the secondary effect of a pro-trombotic environment without inducing bleeding.
The primary objective of the GARDEN study was to evaluate the efficacy of glenzocimab in preventing clinical progression of disease when added to standard of care in COVID-19 patients presenting with ARDS.
In February 2022, Acticor Biotech announced results of this exploratory study conducted in France and in Brazil between December 2020 and June 2021, in a total of 62 randomised patients (30 to glenzocimab and 32 to placebo):
- The safety data analysis confirmed the good tolerability of glenzocimab administered at a daily dose of 1000 mg for three consecutive days
- No difference was shown for the primary efficacy endpoint of progression from moderate to severe respiratory distress between glenzocimab and the placebo, both administered in conjunction with the standard of care.
Acticor Biotech is also evaluating an extension to its clinical development program to include pulmonary embolism and myocardial infarction.
BREATH study is currently designed to compare the safety and efficacy of glenzocimab in the treatment of patients with sub-massive pulmonary embolism treated with increasing doses of alteplase.
LIBERATE study is a planned collaboration with University of Birmingham on a phase 2b clinical trial of glenzocimab in myocardial infarction.
In collaboration with SATT OUEST VALORISATION, Brest University Hospital, Université de Bretagne Occidentale, INSERM and EFS, Acticor Biotech is developing the early genomic profiling of stroke in order to design an emergency point-of-care device that will enable the rapid diagnosis of acute ischemic stroke and initiation of its treatment without additional imaging delays.