Study Design

Asunercept has been evaluated in an Apogenix-sponsored clinical phase II trial in COVID-19 patients in Spain and Russia. The ASUNCTIS trial was a multi-center, randomized, controlled, open-label trial to assess the efficacy and safety of asunercept in patients with severe COVID-19 disease.

The ASUNCTIS trial had four treatment arms to evaluate three different doses of asunercept plus standard of care versus standard of care alone. More than four hundred patients were recruited, with an equal distribution across all four treatment arms.

The primary endpoint was the time to sustained clinical improvement by at least one category on two consecutive days compared to the status at randomization, measured on the clinical performance scale proposed by the World Health Organization. Secondary endpoints included efficacy according to the National Early Warning Score (NEWS), oxygenation requirement, mechanical ventilation requirement, duration of hospitalization including length of stay in the ICU and percentage of patients admitted to the ICU, and mortality on days 15 and 29.

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Study Results

The study was completed in Q4 2021 and top-line results were published in Q4 2022. Full data will be published in a scientific journal.