Immunotherapy shows benefits for hospitalised COVID-19 patients
Apogenix’s asunercept demonstrates efficacy in Phase II trial for the treatment of hospitalised COVID-19 patients.
Apogenix, a biopharmaceutical company developing next generation immunotherapeutics, announced that asunercept showed statistically significant benefits for hospitalised COVID-19 patients in the ASUNCTIS trial.
Apogenix’s lead immunotherapy candidate, asunercept is a fully human fusion protein, consisting of the CD95 receptor and an IgG1 antibody. It is being developed for the treatment of solid tumours, haematological malignancies and viral infections such as COVID-19.
The Phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease. COVID-19 patients were randomised equally into four study arms, receiving 25, 100, or 400mg asunercept (once weekly, i.v.) on top of standard of care (SOC), or SOC alone.
Efficacy was assessed against the WHO-suggested endpoints. The results showed strong trends for clinical efficacy in all treatment groups, indicating a robust activity of asunercept.
Consistently, patients showed faster clinical improvement by approximately 40 percent compared to the control group (8-9 days for the three different treatment groups vs. 13 days with SOC). The combined asunercept dose groups (25, 100 and 400mg arms) revealed statistically significant faster clinical improvement compared to SOC group.
All patients showed a marked reduction of all-cause mortality at all time points and for each dose compared to patients receiving SOC. Furthermore, asunercept reduced the time to recovery from lymphopenia, confirming its presumed mechanism of action. As the extent of lymphopenia correlates with severity of the COVID-19 disease, asunercept accelerates recovery from disease.
Dr Felix JF Herth, Chairman and Head Department of Pneumology and Critical Care Medicine at Thoraxklinik, University of Heidelberg and Chairman of the Data Safety Monitoring Board (DSMB) of the ASUNCTIS trial, commented: “Asunercept is a novel immune-modulating treatment approach which seems to work independently of COVID-19 strains. It combines an excellent safety profile with encouraging efficacy data, warranting the advancement of clinical development and initiation of a pivotal Phase III study.”
Dr Thomas Hoeger, Chief Executive Officer of Apogenix, said:“We are very pleased to see asunercept displaying a robust efficacy and favourable safety profile in the ASUNCTIS trial. Asunercept is expected to prevent the death of immune and lung cells leading to lymphopenia and acute respiratory distress syndrome, thus reducing the number of COVID-19 patients who require intensive care or even die from this disease. Based on our promising Phase II results and given the high need for effective COVID-19 medication in hospitalised patients, we are initiating a pivotal Phase III trial (ASUCOV) with asunercept to confirm the encouraging results in a larger number of patients.”
Asunercept was granted orphan drug designation for the treatment of glioblastoma and myelodysplastic syndromes (MDS) in both the EU and the US. It has also received PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma.