A multicentre Phase I/II double-blind, placebo-controlled study of MRx-4DP0004 in patients with poorly controlled asthma has now commenced. The study will enrol 90 asthma patients not adequately controlled on their current inhaler maintenance therapy. Patients will take MRx-4DP0004 in addition to existing maintenance therapy. This is the world’s first clinical study of a Live Biotherapeutic in patients with poorly controlled asthma. It is anticipated that the results of this study will be available in 2020.
The primary endpoints of this study are safety and tolerability of MRx-4DP0004 when added to long-term maintenance therapy, with secondary endpoints including reduction of asthma symptoms, exacerbations, hospitalisations and the achievement of improved asthma control. The principal investigator for this study is Prof. Chris Brightling, University of Leicester.
This study builds on 4D’s published data (Raftis et al., Scientific Reports 2018) demonstrating that MRx-4DP0004 can significantly reduce both neutrophil and eosinophil airway infiltration concurrently and outperformed standard therapeutics in a preclinical disease model of severe steroid-resistant asthma.
Alex Stevenson, 4D’s Chief Scientific Officer, commented:
“Commencing this study further underlines 4D’s commitment to unlocking the full potential of the gut microbiome and Live Biotherapeutics or ‘LBPs’ to treat diseases beyond the gastrointestinal tract. This year, we have expanded our clinical pipeline to evaluate LBPs in diseases anatomically distant from the gut, firstly in oncology, and now in asthma.”
He added,
“Despite available therapies, many asthma patients struggle to achieve control of their disease and suffer from exacerbations often requiring hospitalisation. The results from this study will be an important proof-of-concept in the development of live biotherapeutics as a next generation therapy in asthma management.”