4D Pharma begins human trials into gut bacteria role in managing severe asthma

By Will Chu

- Last updated on GMT

Live biotherapeutics firm 4D pharma is to commence human trials looking into how effective a microbiota-derived bacterial strain is in managing severe asthma.

The multicentre Phase I/II double-blind, placebo-controlled study represents one of the first clinical studies of a live biotherapeutic in patients with poorly controlled asthma with results expected in 2020.

At the centre of the study is 4D Pharma’s candidate MRx-4DP0004, a commensal Bifidobacterium breve ​strain that Alex Stevenson, 4D’s chief scientific officer, identifies as a “next generation therapy in asthma management”.

“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.

Mouse model encouragement

This study builds on 4D’s published data​ that points to MRx-4DP0004’s ability to reduce both neutrophil and eosinophil airway infiltration in a preclinical disease model of severe steroid-resistant asthma.

Here, the 2018 study finds MRx0004 is effective at reducing airway inflammation in a mouse model of severe asthma by reducing pro-inflammatory signalling proteins secreted by cells.

“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,” ​adds Stevenson.

“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.”

4D Pharma’s micrbiome portfolio includes Blautix (Blautia Hydrogenotrophica​) a single-strain human gut bacteria that may address Irritable Bowel Syndrome (IBS) by consuming gases known to cause bloating, abdominal pain and changes in bowel frequency.

The UK-based firm have completed a successful Phase Ib clinical study of Blautix in IBS patients and are currently conducting a Phase II trial.

4D is also building on research into the gut-brain-axis to discover and develop live biotherapeutics for the treatment of neurodegenerative diseases such as Parkinson's.

Its biotherapeutic candidates MRx0005 (Parabacteroides distasonis​) and MRx0029 (Megasphaera massiliensis​) appear to have complementary characteristics with MRx0005 exhibiting an anti-inflammatory role.

Meanwhile MRx0029 appears to protect neurons from cytotoxicity induced by both environmental and familiar triggers of Parkinson’s disease (PD) and may promote neurodifferentiation and reduce colon permeability.

Pharma and live biotherapeutics

4D Pharma’s progress in the use of gut microbial strains is the latest in a long line of pharmaceutical firms that place the gut microbiome at the centre of research and development efforts.

Live biotherapeutics (LBP) may be a natural progression from current nutritional approaches that do not completely reverse the gut dysfunction and gut microbiota alterations linked with faults in microbial growth.

Last year, French-based biotech start-up Nextbiotix successfully raised €7m in a Series A financing round, to develop microbiome-based approaches that address inflammatory bowel disease (IBD).

The Dijon-based company, which was only founded at the end of 2016, revealed its plans to use the single microbial strain Faecalibacterium prausnitzii​ as a starting point for regulating the immune system, with possibilities to address a number of inflammatory bowel conditions.

Other players in this space include LNC Therapeutics, which together with Cornel University, are looking into the health benefits linked to the Christensenella​ strain.

The commensal bacteria have been associated with lean mass, while its absence has been linked to higher BMI, pre-diabetes, and an increase in many metabolic disease markers in human cohorts. 

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