4D Pharma, the listed Leeds-based pharma company developing Live Biotherapeutics, has announced that its Phase II clinical trial of oral immunomodulator MRx-4DP0004 for patients hospitalised with COVID-19 is now open to enrolment.
The Phase II randomised, double-blind, placebo-controlled trial is enrolling up to 90 patients admitted to hospital with COVID-19 in the UK.
Eligible patients will receive daily oral MRx-4DP0004 or placebo, in addition to standard supportive care.
The primary endpoint of the trial is the mean change in clinical status score as measured by the WHO Ordinal Scale for Clinical Improvement.
In addition, several secondary endpoints assess measures of clinical efficacy including the need for, and duration of, ventilation, in addition to safety and tolerability.
4D pharma’s Live Biotherapeutic MRx-4DP0004 has shown the potential to simultaneously down-regulate specific pathological aspects of the hyper-inflammatory response to viral infection, while maintaining the appropriate anti-viral response.
Both are key factors in the effective treatment of the respiratory symptoms associated with COVID-19, not only for hospitalised patients with more severe disease but potentially also in patients with milder symptoms to prevent disease progression and hospitalisation.
As a Live Biotherapeutic, MRx-4DP0004 is expected to display a favourable safety profile. In an ongoing asthma study MRx-4DP0004 has demonstrated an excellent safety profile to date.
Particularly in the context of the COVID-19 crisis, the safety of this Live Biotherapeutic is critical, in contrast to the known side-effect profiles of other therapies in clinical trials for COVID-19.
“Reducing hyperinflammation, particularly in the lungs, is key to preventing the exacerbation of symptoms associated with more severe COVID-19. 4D pharma has shown MRx-4DP0004 has the ability to target inflammation in the lungs, potentially reducing the respiratory issues central to COVID-19,” said Dr Alex Stevenson, Chief Scientific Officer of 4D pharma.
“4D pharma aims to use this study to generate robust, meaningful clinical data that will support a safe immunomodulatory Live Biotherapeutic intervention for patients hospitalised with COVID-19.”