DDDD.L Regulatory News (DDDD)

4D pharma plc

(the "Company" or "4D")

Thetanix - clinical update and publication of studies

4D announces positive data from Phase Ib study of Thetanix in paediatric Crohn's disease patients and publication of studies showing strong efficacy of Thetanix in preclinical models of IBD

24 September 2018 - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announces positive top-line results for its Phase Ib study of Thetanix in paediatric patients with Crohn's disease. The study achieved its primary objective, demonstrating that Thetanix was well tolerated with a good safety profile.

The randomised, double-blind, placebo-controlled study was conducted in two parts, with a single-dose phase and a multiple-dose phase and treated a total of 18 subjects aged 16-18 with Crohn's disease. In the single-dose phase, eight subjects were given a single dose of either Thetanix or placebo. In the multiple-dose phase, 10 subjects were given either Thetanix or placebo twice daily for seven consecutive days.

The Company also announces the publication of data demonstrating the efficacy of Thetanix in pre-clinical models of inflammatory bowel disease (IBD). The data, published in the journal Inflammatory Bowel Diseases, showed that Thetanix demonstrated strong efficacy on the primary readouts in two different preclinical models with relevance to Crohn's disease, protecting against weight loss, preventing histopathological changes in the colon and attenuating inflammatory mediators.

Using an in vitro co-culture assay, a pirin-like protein (PLP), produced by Thetanix, was also identified as a candidate effector molecule. Recombinant PLP was shown to be protective against colitis in a preclinical model and, like Thetanix, to act on NF-κB signalling in vitro.

Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented: "These promising results add to the growing body of evidence on the efficacy of Thetanix, further reinforcing its potential as a novel treatment for Crohn's disease. Achieving the primary objective of the Phase Ib study, demonstrating the safety and tolerability of Thetanix, is an important milestone in the development of this programme."

The journal article can be found here: https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izy281/5095645

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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/.

About Crohn's disease

Crohn's disease is a chronic inflammatory bowel disease which can occur in any part of the gastro-intestinal tract, but primarily affects the small intestine. Patients suffer from diarrhoea, rectal bleeding and abdominal pain. Many often require long-term medical therapy, are repeatedly hospitalised and may even require surgical intervention. Crohn's disease remains an area of significant unmet medical need. In the mild-to-moderate population, patients are typically treated with long-term immunosuppressants, which are not effective in all individuals and often lead to the development of severe side effects. Safe and effective novel drugs are needed to provide improved treatment options for patients, particularly in the maintenance therapy setting.