Immunic AG
Immunic, Inc. Announces First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment of Patients with Moderate-to-Severe COVID-19
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Immunic, Inc. Announces First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment of Patients with Moderate-to-Severe COVID-19 NEW YORK, July 27, 2020 – Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced enrollment of the first patients in an investigator-sponsored phase 2 clinical trial of the company’s selective oral DHODH inhibitor, IMU-838, for the treatment of patients with coronavirus disease 2019 (COVID-19). The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy and safety of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir (Tamiflu(R)), in approximately 120 adult patients with moderate-to-severe COVID-19. The IONIC trial has been set up with the support of the in-house Trial Management Unit (TMU) of the sponsor and lead site, University Hospitals Coventry and Warwickshire (UHCW) NHS Trust. The IONIC trial has commenced recruitment at the lead site and the TMU is actively engaging with other NHS trusts interested in participating in the trial to facilitate recruitment. “The healthcare community has never faced a more urgent need for new therapies than the unprecedented situation we currently face with the COVID-19 pandemic,” commented Prof. Ramesh Arasaradnam, Gastroenterology Consultant at UHCW NHS Trust, Chair of the British Society of Gastroenterology (BSG) Research Committee and Chief Investigator of the IONIC trial. “Recent third-party research has highlighted the powerful synergy between direct antiviral drugs and DHODH inhibitors in preclinical models. We believe that the combination of Oseltamivir, which is a licensed drug in the United Kingdom, and IMU-838, may offer a promising approach for the treatment of severe viral infections, including mid-to-late-stage COVID-19 patients.” IMU-838 has successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. In cellular assays, IMU-838 demonstrated this antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials. In addition, IMU-838 has an attractive pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650 individuals. The IONIC trial, for which Immunic is providing the study medication, is expected to enroll approximately 120 hospitalized patients, 60 in each treatment arm, with moderate-to-severe COVID-19 who will receive IMU-838 plus Oseltamivir, or Oseltamivir alone, for 14 consecutive days. All patients are also eligible to receive standard-of-care therapy throughout the duration of the study. Inclusion criteria are adult patients with a confirmed or suspected SARS-CoV-2 infection fulfilling clinical status category 3 to 5, as assessed with the seven-point ordinal scale proposed by the World Health Organization (WHO) master protocol. “We are honored 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. “Due to its unique host-based mode of action, which avoids dependence on specific viral proteins and, therefore, offers broad-spectrum antiviral activity, as well as the attractive pharmacokinetic, safety and tolerability profile, we believe that IMU-838 is particularly suitable for combination with other antiviral drugs such as Oseltamivir. We also believe that 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.” In support of the IONIC trial, the UHCW NHS Trust has received funding from the medical research charity LifeArc through its COVID-19 drug repurposing initiative. LifeArc CEO Dr Melanie Lee said, “LifeArc is pleased to be able to support the IONIC trial, as part of our £10 million initiative to find new therapeutics against COVID-19. We believe repurposing already available medicines or those at a late stage of development, like those being studied in the IONIC trial, offers the fastest route to bring benefit to patients during this pandemic.” About IMU-838 About Immunic, Inc. About UHCW NHS Trust 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 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. 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27.07.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |