Treatment showed faster clinical recovery in the combination treatment group
Apogenix asunercept treatment shows statistically significant benefits for hospitalized COVID-19 patients in the Asunctis trial.
An open-label, multicenter Phase 2 trial investigated the efficacy and safety of treatment in 435 patients with moderate to severe COVID-19 disease. Patients were evenly randomized to receive 25, 100, or 400 mg asnercept plus standard of care (SOC).
Efficacy was assessed against WHO-suggested endpoints, including time to clinical improvement according to the WHO scale and mortality. The results show a strong trend of clinical efficacy across all treatment arms, demonstrating strong activity.
Consistently, patients showed approximately 40% faster clinical improvement compared to controls. In addition, all patients receiving asunercept showed significantly reduced mortality at each dose compared to those receiving SOC at all time points.
Furthermore, asnercept shortens the time to recovery from lymphopenia, supporting a presumed mechanism of action. In fact, the degree of lymphopenia correlates with the severity of her COVID-19 illness, so asnercept certainly accelerates her recovery from the disease.
Professor Felix Herth, who chaired the Data Security Oversight Committee during the ASUNCTIS trial, explains: Asunercept is a novel immunomodulatory therapeutic approach that appears to work independently of COVID-19 strains. ”
Apogenix CEO Thomas Hoeger concludes: Asnercept is expected to prevent the death of immune and lung cells that lead to lymphopenia and acute respiratory distress syndrome, reducing the number of his COVID-19 patients who require intensive care or die from the disease. It has been. ”
“Based on the promising Phase 2 results and given the high need for effective COVID-19 therapeutics in hospitalized patients, Asnercept will be used to confirm promising results in a larger number of patients. We are initiating a pivotal Phase 3 trial (ASUCOV) with the drug,” he said. Added.