Biotechnology firm 4D Pharma has dropped plans to test one of its drug candidates in hospitalised Covid-19 patients because there are fewer people with the illness to be enrolled.
The company, which does much of its drug research and development (R&D) in Aberdeen, said the increase in vaccination rates, declining hospitalisation rates, and the progress of its core trial had added to the decision to discontinue enrollment in the phase II study.
In the same announcement, the company confirmed it had reached the next stage in its live biotherapeutic product (LBP) asthma clinical trial, having recruited participants for the first part of its phase I/II evaluation of the drug, MRx-4DP0004.
A total of 30 people with with partly controlled asthma have been enrolled on the 12-week study with top-line results expected in the second half of this year.
Alex Stevenson, 4D Pharma chief scientific officer, said: “The completion of enrolment in Part A of 4D Pharma’s asthma study is an important milestone for this programme.
“This is expected to provide further validation of the favorable safety profile of LBPs as a novel class of drug across a wide range of indications, including respiratory disease.
The completion of enrolment in Part A of 4D pharma’s asthma study is an important milestone for this programme.”
“For the MRx-4DP0004 programme, as Covid-19 hospitalisations 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.”
What are biotherapeutics?
Live biotherapeutics are a relatively new group of medicines that use bacteria in the human body to tackle disease.
MRx-4DP0004 has been shown to significantly reduce lung inflammation and deliver other benefits in asthma, as well as multiple sclerosis and rheumatoid arthritis patients.
The first-in-human Phase I/II trial is a two part, multi-centre, randomised, double-blind, placebo-controlled trial of MRx-4DP0004 in patients taking long-term medication for asthma.
Patients receive oral MRx-4DP0004 or placebo twice daily for 12 weeks.
Aberdeen is home to 4D Pharma’s research centre, although the company’s head office is in Leeds.