Searching for an effective treatment for COVID-19
Apogenix, a biopharmaceutical company developing next-generation immunotherapeutics, is developing asunercept for the treatment of solid tumours, haematological malignancies, and viral infections, such as COVID-19. Asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody.
“Published data indicate that the CD95 ligand – the target of asunercept – plays an important role in the induction of life-threatening lymphopenia, lung damage, and inflammatory cell death in COVID-19 patients,” explains Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix. “By blocking the CD95 ligand, asunercept may reduce these complications reported in COVID-19 patients.”
Phase II trials in COVID-19
The drug candidate is currently being evaluated in an Apogenix-sponsored clinical phase II trial in patients with moderate to severe COVID-19 disease in Spain and Russia. The ASUNCTIS
trial is a multi-centre, randomised, controlled, open-label trial to assess the efficacy and safety of asunercept in patients with moderate to severe COVID-19 disease. It has four treatment arms to evaluate three different doses of asunercept plus standard of care compared to standard of care alone. The aim is to recruit 400 patients, with an equal distribution across all four treatment arms.
Asunercept is further being evaluated in an investigator-initiated trial (IIT) in patients with COVID-19 sponsored by the Medical University of Vienna. This randomised, controlled phase II dose-finding trial will also evaluate three different doses of asunercept plus standard of care compared to standard of care alone. Up to 400 patients with moderate to severe COVID-19 disease may be included in a two-stage recruitment process; the final number of patients to be recruited will be determined based on an interim analysis.
The primary endpoint of both trials is the time to sustained clinical improvement by at least one category on two consecutive days compared to the status at randomisation, measured on the clinical performance scale proposed by the World Health Organisation. Secondary endpoints of both trials include efficacy according to the National Early Warning Score (NEWS), oxygenation requirement, mechanical ventilation requirement, duration of hospitalisation including length of stay in the ICU and percentage of patients admitted to the ICU, and mortality on days 15 and 29.
“In light of the increasing number of COVID-19 cases worldwide, effective treatment options are desperately needed, and we hope that asunercept may prove effective in patients with COVID-19 disease,” says Thomas Hoeger.