4D asthma publication

4D pharma plc

(the "Company" or "4D")

Publication of data in connection with MRx0004

4D announces publication of data highlighting ability of MRx0004 to protect against airway inflammation in severe asthma

Data suggests that MRx0004 is a promising next-generation therapeutic for management of asthma

14 August 2018 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announces the publication of a paper demonstrating that MRx0004, a live biotherapeutic derived from the human gut microbiome, can protect against airway inflammation by reducing both neutrophilic and eosinophilic infiltration in a mouse model of severe asthma.

The paper "Bifidobacterium breve MRx0004 protects against airway inflammation in a severe asthma model by suppressing both neutrophil and eosinophil lung infiltration" (Raftis et al.) is published in the Nature Publishing Group journal Scientific Reports.

Asthma is a phenotypically heterogeneous disease. Between 5 and 10 % of asthma patients have a severe form of the disease which is refractory to steroid treatment and whose symptoms cannot be controlled despite the application of high-intensity treatments. In severe asthma, airway inflammation can be predominantly eosinophilic, neutrophilic, or mixed and patients presenting with neutrophilic inflammation have particularly poor treatment options. Severe asthma is estimated to account for more than 60 % of asthma-associated healthcare costs.

MRx0004 is a strain of Bifidobacterium breve isolated from the gut microbiome of a healthy human. It was tested prophylactically and therapeutically in a house dust mite mouse model of severe asthma. A strong reduction of neutrophil and eosinophil infiltration was observed in lung bronchoalveolar lavage fluid (BALF) following MRx0004 treatment. Furthermore, MRx0004 had a striking effect on lung histopathology, with a strong reduction of both peribronchiolar and perivascular inflammatory infiltrate. The efficacy of MRx0004 exceeded that of the anti-IL-17 positive control used in the experiment.

Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented: "This data provides further evidence that live biotherapeutics have the potential to change the way we treat disease. Using MRx0004, we have demonstrated superior efficacy to biologics in a severe and steroid-resistant model of asthma."

He added: "Perhaps more significantly, we have shown that MRx0004 can strongly reduce neutrophil and eosinophil airway infiltration concurrently. This is something which is not achievable with current therapies and is further evidence of the potential of MRx0004 as a next-generation therapeutic for the management of asthma."

Please find a copy of the paper here: http://www.nature.com/articles/s41598-018-30448-z

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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 bacteria, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform that rationally identifies novel bacteria that have a precise and evolved therapeutic effect. All of 4D's live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D has completed a phase I study in Irritable Bowel Syndrome and has completed dosing in a phase I study in Paediatric Crohn's Disease. It currently has a pipeline of 13 pre-clinical programmes, covering disease areas such as cancer, poorly controlled asthma, autoimmune and CNS disease, and plans to commence four additional clinical studies in 2018. For more information, refer to https://www.4dpharmaplc.com/.