4th Jun 2021 10:32
(Alliance News) - 4D Pharma PLC on Friday said it has discontinued enrolment in its phase two study of MRx-4DP0004 for treating hospitalised patients with Covid-19 in the UK.
The Leeds-based live biotherapeutic products developer said the reason for the discontinuation was higher vaccination rates, declining hospitalisation rates, and progress in the MRx-4DP0004 asthma clinical trial.
Concerning the trial, 4D Pharma announced the completion of its target enrolment of 30 patients for Part A of its phase I/II clinical trial of MRx-4DP0004 in patients with partly-controlled asthma. The company expects to announces topline results for this part of the trial within the second half of 2021.
The primary endpoint of part A of the trial is safety and tolerability. Meanwhile, the secondary and exploratory endpoints for part A, include a range of clinical measures of lung function and quality of life, and a suite of sputum and blood immune biomarkers.
MRx-4DP0004 is an oral, immunomodulatory, single strain LBP, and has been demonstrated to treat severe asthma by reducing airway inflammation.
"For the MRx-4DP0004 program, as Covid-19 hospitalizations continue to decline with the increase in vaccinations, the voluntary discontinuation of enrolment into our Covid-19 study enables 4D pharma to focus our efforts and resources on developing our novel LBP for the treatment of asthma. We look forward to elucidating important findings regarding the potential of our oral, gut-restricted, single strain LBPs to exert potent effects on the human immune system with therapeutic effects in organs and tissues away from the gut," said Chief Scientific Officer Alex Stevenson.
Shares in 4D Pharma were down 3.6% at 93.05 pence on Friday in London.
By Dayo Laniyan; [email protected]
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