4D pharma, a UK-based developer of live biotherapeutics, has secured regulatory acceptance to commence a Phase II study in patients with COVID-19.
The listed pharma company will study its live biotherapeutic, MRx-4DP0004, the first immunomodulatory therapy being tested in patients hospitalised with COVID-19 which has shown the potential to simultaneously down-regulate specific pathological aspects of the hyper-inflammatory response while maintaining the appropriate anti-viral response
As MRx-4DP0004 is not broadly immunosuppressive, it does not carry the inherent side-effects associated with immunosuppressants currently under investigation, such as increased risk of infections or cancer, that may preclude their use earlier in more mild-to-moderate patients, which is crucial to reducing the burden on health systems.
MRx-4DP0004 is an orally administered, single-strain Live Biotherapeutic product (LBP) currently in a Phase I/II clinical trial for the treatment of patients with partly-controlled asthma.
4D pharma has previously shown that MRx-4DP0004 is able to significantly reduce lung inflammation and impact particular immune cell types and pathways implicated in the hyperinflammatory response to SARS-CoV-2 infection.
MRx-4DP0004 has a highly attractive safety profile with no drug-related adverse safety signals observed in preclinical studies or in patients dosed to date. As such, 4D pharma believes MRx-4DP0004 may be safely administered to patients hospitalised with COVID-19 symptoms to prevent or reduce the onset of severe inflammation.
The COVID-19 Phase II study of MRx-4DP0004 will be a randomised, double-blind, placebo-controlled trial. It will evaluate the efficacy and safety of MRx-4DP0004 in addition to standard-of-care in up to 90 patients hospitalised with symptoms indicative of COVID-19. Eligible participants will be randomised 2:1 to receive 14 days of treatment with either MRx-4DP0004 or placebo (two capsules twice daily).
Participants will be monitored daily throughout the treatment period for improvement or progression of COVID-19 symptoms and adverse events. Following completion of the treatment period, participants will be followed-up at approximately 14 and 28 days post treatment.
The primary endpoint of the trial will be the mean change in clinical status score as measured by the WHO Ordinal Scale for Clinical Improvement. Secondary endpoints include safety and tolerability as well as a suite of additional measures of clinical efficacy including the need for and duration of ventilation.
The study’s Lead Investigator is Dr Dinesh Saralaya, Consultant Respiratory Physician and Associate Director of Research at Bradford Teaching Hospitals NHS Foundation Trust, and the National Institute for Health Research’s (NIHR) Clinical Lead for Respiratory industry studies.
“As well as its appropriate mechanism of action, the highly favourable safety profile of MRx-4DP0004 makes it a particularly attractive candidate for COVID-19 patients, and may potentially allow us to prevent or delay their progression to requiring ventilation and intensive care,” she said.