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The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.
4D pharma, a pharmaceutical company headquartered in the United Kingdom, announced on April 20, 2020 that it has received expedited acceptance from the UK Medicines and Healthcare products Regulatory Agency to launch a phase-II study of MRx-4DP0004, a single-strain live biotherapeutic product, in patients with COVID-19.
According to a company press release, the phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the biotherapeutic in 90 individuals with COVID-19 symptoms. Participants will receive 14 days of treatment twice daily and will be followed up with 14 to 28 days after treatment.
“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,” said Alex Stevenson, chief scientific officer, 4D pharma, in the press release. “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 COVID-19 pandemic presents an unprecedented challenge to our healthcare systems and we desperately require the rapid development of new therapies to ease the burden on our intensive care units,” added Dr. Dinesh Saralaya, the study’s lead investigator, in the press release. “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. As well as its appropriate mechanism of action, the highly favorable 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.”
Source: 4D pharma