University Hospitals Coventry and Warwickshire (UHCW) NHS Trust and Immunic, Inc. enrol first patient in clinical trial to treat moderate to severe COVID-19

University Hospitals Coventry and Warwickshire (UHCW) NHS Trust is pleased to announce the enrolment of the 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 (TamifluÒ) – 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.

“The healthcare community has never faced a more urgent need for new, innovative treatments than the unprecedented situation we currently face with COVID-19,” said Professor Ramesh Arasaradnam, a Gastroenterology Consultant at UHCW NHS Trust, the Chair of the British Society of Gastroenterology (BSG) Research Committee and Chief Investigator of the IONIC trial.

“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 into the IONIC trial at UHCW NHS Trust and other UK hospitals.

The randomised, open label trial will compare the efficiency and safety profile of standard care with IMU-838 and Oseltamivir (TamifluÒ) versus standard care with Oseltamivir (TamifluÒ) alone for 14 consecutive days.

“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,” noted Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.

“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, commented: “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.”

Notes to editors:

About IMU-838

IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 trials in patients with COVID-19, relapsing-remitting multiple sclerosis, where top-line data is expected in the first half of August 2020, and ulcerative colitis. Furthermore, Immunic’s collaboration partner, the Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis. To date, IMU-838 has already been tested in about 650 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile.

About UHCW NHS Trust

University Hospitals Coventry and Warwickshire (UHCW) NHS Trust is one of the largest acute teaching Trusts in the UK, comprising University Hospital in Coventry and the Hospital of St Cross in Rugby and working in partnership with Warwick University Medical School and Coventry University. It has over 9,000 staff and delivers services across the West Midlands region. This includes hosting region-wide services such as the Coventry and Warwickshire Pathology Network and the North West and Midlands Bowel Cancer Screening hub. The Trust works closely with its partners in health and social care in Coventry/Warwickshire to develop patient-focused services that meet the needs of our communities.

The Research and Development Department at the Trust supports and delivers a wide range of high quality health research for the benefit of our patients. In 2019-20, the department recruited 4,295 patients into research projects - demonstrating the Trust’s commitment to improving the quality of care and contributing to wider health improvement. The team recruited more COVID-19 patients per head of population than the national average, supporting the World Health Organisation ‘ISARIC’ trial and the National Institute for Health Research ‘Recovery’ study which demonstrated the efficacy of low dose Dexamethasone as an effective treatment for COVID-19.

Contact Information

UHCW NHS Trust

Gavin Hawes

Senior Communications Officer

University Hospitals Coventry & Warwickshire

+44(0)2476 965068

communications@uhcw.nhs.uk


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