Therapy showed faster clinical recovery for combined treatment groups
Apogenix’s asunercept treatment has shown statistically significant benefits for hospitalised COVID-19 patients in its Asunctis trial.
The open-label multi-centre phase 2 trial investigated the efficacy and safety of the therapy among 435 patients with moderate-to-severe COVID-19 disease. Patients were randomised equally, receiving 25, 100 or 400mg of asunercept and standard of care (SOC).
Efficacy was assessed against the WHO-suggested endpoints, including time to clinical improvement according to WHO scale and mortality. The results showed strong trends for clinical efficacy in all treatment groups, indicating robust activity.
Consistently, patients showed faster clinical improvement by approximately 40% compared to the control group. Furthermore, all patients receiving asunercept showed a marked mortality reduction at all time points, and for each dose, compared to patients receiving SOC.
Furthermore, asunercept reduces the time to recovery from lymphopenia, confirming its presumed mechanism of action. Indeed, as the extent of lymphopenia correlates with the severity of COVID-19 disease, asunercept duly accelerates recovery from disease.
Professor Felix Herth, chairman of the Data Safety Monitoring Board during the ASUNCTIS trial, explained: “Despite some progress in the treatment of hospitalised COVID-19 patients requiring additional oxygen, there still remains a high unmet medical need for this patient group. Asunercept is a novel immune-modulating treatment approach which seems to work independently of COVID-19 strains.”
Thomas Hoeger, chief executive officer of Apogenix, concluded: “We are very pleased to see asunercept displaying a robust efficacy and favorable 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 2 results and given the high need for effective COVID-19 medication in hospitalised patients, we are initiating a pivotal phase 3 trial (ASUCOV) with asunercept to confirm the encouraging results in a larger number of patients,” he added.
by John Pinching
https://www.pharmatimes.com
