MHRA fast track nod for UK pharma company’s COVID-19 study

UK pharma company gets expedited MHRA acceptance to start Phase II COVID-19 study

4D pharma has received expedited acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase II study of MRx-4DP0004 in patients with COVID-19.

4D pharma’s Live Biotherapeutic MRx-4DP0004 is 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.

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. There is an urgent need for a safe and effective therapy to prevent and treat the severe inflammatory symptoms of COVID-19, to alleviate the significant burden on hospitals and intensive care units. Targeted immunomodulation may be beneficial in these patients.

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 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.

Alex Stevenson, Chief Scientific Officer, 4D pharma, said: “As the global SARS-CoV-2 pandemic has developed and the UK has emerged as one of the worst affected areas, 4D pharma has worked intensively with our clinical collaborators and regulatory agencies to bring an urgently needed potential therapy to patients as rapidly as possible.

“If, as we believe, MRx-4DP0004 is successful in this study it would represent a highly significant breakthrough in the fight against the coronavirus pandemic.”

The study’s Lead Investigator, 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 Clinical Lead for Respiratory industry studies, said: “The COVID-19 pandemic presents an unprecedented challenge to our healthcare systems…Given the scale and urgency of the situation it is vitally important that we generate evidence to support the use of new candidates as quickly as possible, before these can be rolled out to patients who need them.”