The clinical trial is exploring the effectiveness of IMU-838 in combination with Tamiflu to treat patients with COVID-19.
University Hospitals Coventry and Warwickshire (UHCW) has this week announced the enrolment of its first patient into a clinical trial of biopharmaceutical company Immunic’s oral DHODH inhibitor, called IMU-838, for the treatment of patients with COVID-19.
This is the only trial worldwide exploring the effectiveness of IMU-838 in combination with Oseltamivir (Tamiflu) – one of the most widely used flu treatments in the UK – in patients with moderate to severe COVID-19.
Clinical improvement will be assessed on an ordinal scale through composite scores used in COVID-19 and influenza trials by the World Health Organisation.
Professor Ramesh Arasaradnam, a Gastroenterology Consultant at UHCW, explained that “the healthcare community has never faced a more urgent need for new, innovative treatments than the unprecedented situation we currently face with COVID-19”.
“Third-party research has highlighted the powerful synergy between direct antiviral drugs and DHODH inhibitors in preclinical models.
“Although these results require corroboration in larger studies and in individuals infected with COVID-19, we believe that the combination of IMU-838 and Oseltamivir may offer a promising approach for the treatment of severe viral infections, including moderate to severe COVID-19 patients.
“The data collected may be able to provide us useful insights in the management of patients during the upcoming flu season later in the year.”
Approximately 120 consenting patients with moderate to severe COVID-19 symptoms are planned to be enrolled in the IONIC trial at UHCW and other UK hospitals.
The randomised, open-label trial will compare the efficiency and safety profile of standard care with IMU-838 and Oseltamivir versus standard care with Oseltamivir alone for 14 consecutive days.
Daniel Vitt, Ph.D., president of Immunic, commented: “We are honoured to be collaborating with the UHCW NHS Trust on this important clinical trial, in order to find a new treatment option for COVID-19 patients.
“This trial can provide valuable insights as to whether the host cell-based antiviral mechanism of IMU-838 has a synergistic effect with a direct antiviral drug in order to provide a combination treatment approach for COVID-19.”
Professor Arasaradnam, supported by the in-house Trial Management Unit (TMU) at UHCW, secured funding for the IONIC trial from the medical research charity LifeArc.
Melanie Lee, CEO of LifeArc, added: “LifeArc has made £10m available for the development of new therapeutics to support the global effort against COVID-19.
“Repurposing already available drugs or those in the late stage of development offers the fastest route to bring benefit to patients at this critical time.”