DDDD.L Regulatory News (DDDD)

4D pharma plc

(the "Company" or "4D")

Clinical Update - MRx-4DP0004 Asthma Programme

4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces an update on its lead Live Biotherapeutic candidate for asthma, MRx-4DP0004.

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."

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About 4D

Founded in February 2014, 4D is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform that rationally identifies novel bacteria based on a deep understanding of function and mechanism. 4D's Live Biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D has four clinical studies in progress, namely a Phase II clinical study of Blautix in Irritable Bowel Syndrome, a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours and a Phase I/II study of MRx-4DP0004 in asthma. Other focus programmes include disease areas such as CNS disease. 

About Asthma

Asthma is an inflammatory disease of the lungs characterized by recurring symptoms, reversible airflow obstruction, and bronchospasm. Between 5-10% of asthma patients have the severe form of the disease, which is refractory to steroid treatment and cannot be controlled with high-intensity treatments and accounts for more than 50% of asthma associated healthcare costs. There is a growing body of evidence linking the gut microbiome to the development of asthma. The asthma therapeutics market is projected to reach to $23.1 billion by 2023

In severe asthma, airway inflammation can be predominantly eosinophilic, neutrophilic or mixed. Whilst a number of biologics have recently been approved to treat patients with eosinophilic disease, there are currently no approved therapies for patients who present with a neutrophilic phenotype.

About MRx-4DP0004

MRx-4DP0004 has demonstrated strong and significant efficacy in industry standard preclinical models of steroid-resistant severe asthma. It was shown to reduce both neutrophils and eosinophils in both prophylactic and therapeutic settings. The efficacy was also reflected in a reduction in histopathological lung inflammation, and specific subsets of T cells and dendritic cells.

Notably, MRx-4DP0004 outperformed the anti-IL-17 positive control in this model and was able to reduce airway neutrophils and eosinophils concurrently, which is not achievable with existing therapeutics. In addition to standard maintenance therapy such as inhaled corticosteroids (ICS) and long acting beta agonists (LABA), MRx-4DP0004 may provide benefits to patients with only partly controlled asthma.

For more information about the clinical study please visit https://clinicaltrials.gov/ct2/show/NCT03851250

For more information, refer to https://www.4dpharmaplc.com/