First patient dosed in avdoralimab phase II clinical trial in COVID-19 patients with severe pneumonia.- Innate Pharma SA.

Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia. The primary objective of this investigator-sponsored tial, named FORCE, is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS.

The Phase II 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/C5aR pathway.

About the clinical trial : FORCE is a multi-center, randomized, double-blind, placebo-controlled Phase II trial evaluating avdoralimab in COVID-19 patients with severe pneumonia. The trial will be conducted in La Timone Hospital and Nord Hospital in Marseille (Hopitaux Universitaires de Marseille – AP-HM) and in the Hospital Laveran (HIA-Laveran). The trial is expected to enroll a total of 108 patients (age 18-80) between two cohorts: one cohort of COVID-19 patients with severe pneumonia without acute respiratory distress syndrome (ARDS) at baseline and one cohort of COVID-19 patients with severe pneumonia complicated by ARDS and admitted in ICU at baseline. In each cohort, patients will receive avdoralimab or placebo.

“The intensive care units are currently overburdened in France, along with every country affected by the pandemic. Hospitalization in intensive care units is often long, from 14 to 21 days, and physicians have no effective treatments for patients. The objective of this study is to investigate whether avdoralimab can reduce the duration of hospitalization, and the duration and need for mechanical ventilation in an important proportion of COVID-19 patients,” explains Pr. Nicolas Schleinitz, MD, Internal Medicine Service, Timone Hospital, Professor at AP-HM, Aix-Marseille University and Principal Investigator for the FORCE study.