APEIRON Biologics AG, a biotechnology company with an approved product on the market as well as a broad preclinical and clinical pipeline, today announced the launch of a Pilot investigator-initiated clinical trial (IIT) with APN01, a recombinant human angiotensin-converting enzyme 2 (rhACE2), to treat patients with severe coronavirus infection in the People's Republic of China.
The randomized, unblinded trial will treat 24 patients for seven days to obtain preliminary data on the impact of rhACE2 on biological, physiologic, and clinical outcomes, as well as safety in patients with severe SARS-CoV-2 infection. These data will be assessed to ascertain whether a Phase 2B clinical trial in a larger number of patients is warranted.
The trial is being supported by a global team of leading experts: Intensive care specialist, Prof. Arthur Slutsky, Scientist, St. Michael's Hospital, Toronto, and Prof. of Medicine, Surgery and Biomedical Engineering at the University of Toronto (Toronto, Canada) and Prof. Haibo Zhang, Prof. of Anesthesiology, St. Michael's Hospital, University of Toronto; Prof. Nanshan Zhong and Prof. Yimin Li, both of the Guangzhou Institute of Respiratory Health and leading physicians in fight against COVID-19 in China, will oversee the trial; and Prof. Josef Penninger, Scientific Director and Professor of the Life Science Institute of the University of British Columbia, Canada.
To address this unfortunate crisis and dreadful disease our team has at short notice been able to bring together a worldwide team of experts and scientists. Our drug candidate APN01 has been proven safe and well tolerated in patients in previous clinical PhI and PhII trials. We are delighted and proud that we can now start treating infected patients in China." Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics AG Related Stories
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