Innate Pharma SA (IPHA) announced Tuesday that the investigator-sponsored Avdoralimab Phase 2 FORCE Trial in COVID-19 Patients with severe pneumonia did not meet primary endpoints in all three cohorts of the trial.
Based on these results, the company will stop exploring avdoralimab in COVID-19.
Meanwhile, the company will continue its investigator-sponsored Phase 2 trial of avdoralimab in bullous pemphigoid, an inflammatory disease, which is currently enrolling patients. More than 100 patients have been treated with avdoralimab in inflammation and oncology clinical trials with no new or unexpected safety signals observed.
The company noted that the Phase 2 FORCE (FOR COVID-19 Elimination) clinical trial evaluated the safety and efficacy of its anti-C5aR1 antibody, avdoralimab, in COVID-19 patients with severe pneumonia.
The FORCE trial was initiated based on pre-clinical data showing that patients who progress towards severe COVID-19 disease exhibit an activation of the C5a/C5aR1 pathway. These translational data were observed in the trial; however, they did not translate into clinical benefit over best supportive care.
According to the company, investigators and the Independent Data Monitoring Committee observed slightly higher deaths in the treatment arm compared to placebo without causality being established.
Results from this trial, including translational data, are planned to be submitted for publication.
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