On Jul. 28, 2020, Apogenix announced that it had received regulatory approval to start a clinical phase II trial with asunercept in COVID-19 patients in 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 plan was to include additional study centers in other European countries, in particular Spain. Published data indicate that the CD95 ligand (CD95L) – the target of asunercept – plays a role in the induction of life-threatening lymphopenia, lung epithelial damage, and inflammatory cell death in COVID-19 patients. By blocking CD95L, asunercept could reduce these complications reported in COVID-19 patients.

The ASUNCTIS trial will have four treatment arms to evaluate three different doses of asunercept plus standard of care versus standard of care alone. A total of 400 patients will be recruited, with an equal distribution across all four treatment arms.

The primary endpoint is 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 include 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.