27 July 2020
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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IMPORTANT INFORMATION ON BLOOD TESTING DUE TO COVID-19
If you are experiencing symptoms associated with COVID-19, e.g. fever, loss of taste or continuous new cough, please DO NOT attend for a blood test.
Earlier this year, the Government revised the guidance on Shielding for CEV patients. All those who have been identified as CEV have been advised to follow the same guidance as everyone else, whilst potentially thinking about extra precautions you could take to reduce your chance of catching COVID-19.
Taking into account this guidance, and the evidence that most patients have now resumed having their blood tests at their usual preferred location, UHCW will no longer be providing the Shielding phlebotomy service from Monday 13 December 2021. You will need to make arrangements to get your blood tests done, as you did prior to the pandemic at locations across Coventry and Warwickshire at www.uhcw.nhs.uk/bloodtests If your specialist has requested a blood test which is due to be taken prior to Monday 13th December, you can expect it to take place at a ‘Pop-up’ clinic, as before. Any blood tests required after this date will need to be a booked appointment.
You can keep up to date with the latest advice from the Government and from UHCW on the following website: www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19
Click on the map for information about phlebotomy clinics in Coventry. You can book an appointment online at the locations in red.
Please book an appointment before attending for a blood test. Click on the ‘Book Online’ button above. Booking an appointment helps patients, their carers and family members to plan their hospital visit better, helping to reduce clinic waiting times and enabling patients to be seen much more quickly.
Location: Outpatients Department, on the ground floor. Opening hours: 8am-4.45pm, Monday to Friday (excluding bank holidays).
Children under 16 years old will need to book online here.
Please book an appointment before attending for a blood test, click on the ‘Book Online’ button above. Patients from Rugby and the surrounding areas are able to access the Friends Blood Taking Unit at the Hospital of St Cross.
Referrals for blood tests can be from GP's, practice nurses or from hospital consultants. Patients are also able to leave other samples, such as urine, which have been collected at home, at the hospital's Pathology Reception.
Location: Near Brookfield House, just off North Road - map here. Opening hours: The blood taking clinic sessions for adults and children are listed below:
Monday -Friday 7am-4:45pm Appointment only
Wednesday Evening 5pm-7pm Suspended due to COVID
Saturday Morning 7am-10pm Suspended due to COVID
April 2020 NEW - This Clinic is now by appointment. Please book an appointment before attending for a blood test. Click on the ‘Book Online’ button above.
Address: Stoney Stanton Road, Coventry CV1 4FS Location: Access is via the main doors, the Phlebotomy team are in Area A. Opening hours: Monday to Friday (excluding bank holidays). 8am–4.45pm
Glucose Tolerance Test (GTT)
Specialist Tests - There are a small number of specialist tests where blood needs to be taken on a hospital site as the sample must be transferred to the laboratory rapidly for the test to be undertaken. Click here for a list of these specialist tests and to find out more.