Immutep (ASX:IMM) has signed an agreement with the University Hospital Pilsen in the Czech Republic that will enable an investigator-initiated randomised phase two clinical trial of its lead product candidate eftilagimod alpha (efti) in hospitalised patients with COVID-19.
The company said the Czech Republic’s State Institute for Drug Control had granted the necessary approvals with the recruitment of patients expected to commence immediately. It said initial interim results are expected to be reported from early 2021.
The company said the trial aims to boost a patient’s immune response to prevent the development of severe COVID-19 symptoms that require intensive care and can lead to respiratory failure and death.
Immutep will provide efti at no cost to the University Hospital Pilsen. The hospital will fund the study. The trial will be led by Professor Martin Matejovic who is the Head of Medical Department at University Hospital Pilsen, Professor of Medicine at University Hospital Pilsen and Charles University Medical School.
It will also be conducted in collaboration with Dr Dalibor Sedlacek, Associate Professor of Medicine and Head of the Department of Infectious Diseases, along with Dr Marek Nalos, Associate Professor of Medicine and Head Medical ICU at Department of Intensive Care Medicine of the Nepean Hospital, Sydney.
Trial participants will receive subcutaneous injections of efti (10 mg) on days one, three and seven, in addition to standard care. The primary endpoint is the patient’s clinical status at day 15 as per the WHO recommended evaluation scale.
Immutep CEO, Marc Voigt, said, “We were delighted to be approached for this study by Dr Marek Nalos and Professor Martin Matejovic. It is highly encouraging that efti, with its broad mechanism of action, attracts keen interest from clinicians who are willing and able to fund the research and commit their time to further exploring efti’s potential to fight diseases.
"While Immutep’s focus remains on cancer and autoimmune disease, this new trial gives us the opportunity to contribute to the global efforts to beat COVID-19. We believe efti is currently the only APC activator of its kind being evaluated against COVID-19 in a randomized Phase II trial and that the study will contribute to our further understanding of its potential in infectious diseases in general.”