4D pharma plc, a pharmaceutical company developing Live Biotherapeutics, received expedited acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II study of MRx-4DP0004 in COVID-19 patients.

Current evidence suggests a reason for the high mortality rate of COVID-19 may be due to the hyper-inflammatory response and cytokine storm syndrome caused by uncontrolled activation of the immune system. Targeted immunomodulation may be beneficial in these patients.  

4D pharma’s Live Biotherapeutic MRx-4DP0004 is the first immunomodulatory therapy being tested in patients hospitalized 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.

The COVID-19 Phase II study of MRx-4DP0004 will be a randomized, double-blind, placebo-controlled trial that will evaluate efficacy and safety in addition to standard-of-care in up to 90 patients. The primary endpoint of the trial will be the mean change in clinical status. 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.