UNION Receives Approval From Danish Medicines Agency to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

• Niclosamide has been identified as a potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea, with potency >40x higher than remdesivir
• UNION has leveraged existing deep knowledge of niclosamide, derivatives and formulation technologies to rapidly advance a treatment candidate for COVID-19
• The Danish Medicines Agency has approved UNIONs Clinical Trial Application to initiate study with niclosamide in healthy volunteers
• The COVID-19 program has been awarded financial support from the Innovation Fund Denmark

COPENHAGEN, Denmark, July 1, 2020 /PRNewswire/ -- UNION therapeutics A/S ("UNION"), a privately held clinical stage pharmaceutical company dedicated to the discovery and development of novel medicines for patients with unmet medical needs in inflammatory and infectious diseases, announced this morning that the Danish Medicines Agency has approved initiation of a clinical study with an optimized salt form of niclosamide as a new treatment candidate for COVID-19.

Chief Medical Officer of UNION, Dr. Philippe Andres states: "The approval of our Clinical Trial Application is a major milestone, enabling us to further assess the safety and tolerability profile of UNI911 which has the potential to be a uniquely differentiated treatment candidate for COVID-19".

Over a number of years, UNION has built a deep understanding of niclosamide and its mechanism of action. Professor Morten Sommer, Chief Scientific Officer and Co-founder of UNION, explains: "Niclosamide is a truly differentiated candidate for the treatment of COVID-19, with its method of action, effectively blocking replication of SARS-CoV-2 by targeting host cells to disrupt the viral life cycle. The extensive experience and data generated to date by UNION with niclosamide, and in particular optimized salt forms thereof, have enabled rapid progress leading to the successful approval of the Clinical Trial Application".

CEO and Co-founder of UNION, Dr. Rasmus Toft-Kehler concludes: "UNION has been through an amazing period of process leading to approval of the Clinical Trial Application. The team, including all stakeholders, partners, physicians, Innovation Fund Denmark, The European Investment Bank, global organizations, investors and not least regulatory authorities, have acted with passion and in concert to advance UNI911 at an incredible pace. We are honored to be part of this venture and excited to be at the cusp of initiating clinical studies with the ultimate goal of making a differentiated product available for patients in need".