Avdoralimab (IPH5401) is a therapeutic antibody that specifically binds and blocks C5a receptors (C5aR1) expressed on subsets of myeloid-derived suppressor cells (MDSC) and neutrophils. Targeting C5a/C5aR1 has been demonstrated scientifically and through positive clinical trials in some complement-driven inflammatory diseases.
Avdoralimab is being investigated in clinical trials for inflammatory illnesses and COVID-19.
The Company is pursuing investigator-sponsored trials in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be strongly involved in the physiopathology of the disease.
A Phase 2 trial evaluating avdoralimab in patients with BP is currently recruiting.
C5a has been implicated in the pathogenesis of ARDS by promoting a proinflammatory environment, through the attraction of neutrophils and stimulation of immune cells such as T and B cells to release cytokines. Avdoralimab blocks C5aR1 and has the potential to reduce the inflammatory response in the lungs.
In April 2020, Innate announced that the first patient was dosed in a randomized, double-blind, investigator-sponsored Phase 2 clinical trial evaluating the safety and efficacy of avdoralimab in COVID-19 patients with severe pneumonia.
The trial, named FORCE (FOR COVID-19 Elimination), is sponsored by Hopitaux Universitaires de Marseille (AP-HM).
FORCE is expected to enroll a total of 208 patients (age 18-80) between the three cohorts:one cohort of COVID-19 patients with severe pneumonia without acute respiratory distress syndrome (ARDS) at baseline, one cohort of COVID-19 patients with severe pneumonia complicated by ARDS and admitted in ICU at baseline and one cohort of COVID-19 patients with ARDS requiring mechanical ventilation. In each cohort, patients will receive avdoralimab or placebo.
The Phase 2 trial is supported by an exploratory translational study, EXPLORE COVID-19, which suggests that patients who progress towards severe COVID-19 disease exhibit an activation of the C5a/C5aR1 pathway. Results from EXPLORE COVID-19 were published in Nature.
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