Privately-held Austrian biotech APEIRON Biologics announced today that APN01 (alunacedase alfa) treatment showed statistically-significant improvements in specific areas for severely ill COVID-19 patients.
APEIRON designed this study in March 2020 as one of the first trials to treat hospitalized patients with the then new SARS-CoV-2 virus. The trial was conducted in Austria, Germany, Denmark and Russia. The multicenter, double-blind, randomized, placebo-controlled, interventional Phase II trial assessed the safety, tolerability and efficacy of APN01 in 178 patients with severe COVID-19 compared to placebo. Both groups, APN01 (n=88) and placebo (n=90), also additionally received standard of care (SOC). Patients received treatment for seven days with follow-ups until day 28. March 15, 2021
“We are delighted to see that treatment with APN01 has demonstrated promising clinical benefits for patients with severe COVID-19,” said Peter Llewellyn-Davies, chief executive of APEIRON Biologics, adding: “Our treatment has now been evaluated for the first time in patients with COVID-19….We will now discuss the further development of APN01 with investigators, advisors and regulatory authorities in order to realize an important therapeutic option for this deadly disease.”
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