Heidelberg, Germany, July 28, 2020–Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced today that it has received regulatory approval to start a clinical phase II trial with asunercept in COVID-19 patients in Russia. The ASUNCTIS trial will be a multi-center, randomized, controlled, open-labeltrial to assess the efficacy and safety of asunercept inpatients with severe COVID-19 disease. The plan is 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 byat least one category on two consecutive days compared to the status at randomization,measuredon 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.
“We are very pleased to have received approval by the regulatory authorities in Russia to initiate ourfirst clinical trial withourlead immunotherapy candidate asunerceptin patients with severe COVID-19 diseaseand hope to expand the trial to other countries, such as Spain, soon,” said Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. “The excellent safety and tolerability of asunercept havealready been demonstrated in clinical trials in recurrent glioblastoma and myelodysplastic syndromes. We look forward to exploring the potential of asunercept in the treatment of COVID-19 patients.”