4D Pharma reveals coronavirus causing delays to drug studies

DRUG MAKER 4D Pharma said the coronavirus pandemic has had unavoidable impacts on some of its activities, resulting in some potential delays to expected clinical readouts.

The Leeds-based firm said it is monitoring the situation closely and will provide updates when the expected resolution of the situation becomes clearer.

The group’s chief executive, Duncan Peyton, said: “2019 saw another world first for live biotherapeutics delivered by 4D, in the area of respiratory disease.

“We commenced a Phase I/II randomised, placebo-controlled trial of MRx-4DP0004 in partly controlled asthma in July, evaluating the safety and tolerability of MRx-4DP0004 in combination with existing maintenance therapy, with a range of secondary endpoints to evaluate efficacy.

“Unfortunately, the global Covid-19 pandemic has had a significant impact on recruitment for the study as we have a duty to prioritise the safety of our patients in this high risk group and the wellbeing of the medical staff involved.”

He said the firm is monitoring the situation closely and will be able to provide updates as the impact on the trial becomes clearer

“However, with great challenges come great opportunity and social obligation,” he said.

“The primary burden on healthcare systems caused by SARS-CoV-2 infection is the hyperinflammatory response which leads to the need for mechanical ventilation and admission to intensive care. There is a clear and urgent need for an immunomodulatory therapeutic to prevent or reduce hyperinflammation associated with severe disease.”

He said that as the scientific community’s understanding of the immunology of Covid-19 has developed, it became clear that the unique immunomodulatory activity of MRx-4DP0004 may be able to address this critical gap in the management of Covid-19 – to prevent or reduce hyperinflammation in hospitalised patients.

4D is conducting a trial to demonstrate clinical benefit in addition to standard of care. The trial has received expedited acceptance from the UK’s MHRA, and preparations are advancing quickly to begin dosing patients.