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4D Pharma starts first trial in asthma

4D Pharma starts first trial in asthma – UK microbiome biotech 4D Pharma  (DDDD) has started a clinical trial of a live biotherapeutic, MRx-4DP000, in asthma, the first time such a drug concept has been tested in this condition.

The double-blind, placebo-controlled Phase I/II study will enrol 90 patients whose asthma is inadequately controlled on inhaled therapy. Patients will take MRx-4DP0004 or placebo in addition to existing maintenance therapy and the primary endpoints are safety and tolerability, with secondary endpoints including reduction of asthma symptoms, exacerbations, hospitalisations and the achievement of improved asthma control. Results are expected to become available in 2020.

4D’s live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The company has three other clinical studies underway: one, a Phase II study of Blautix in irritable bowel syndrome, and two others with MRx0518 in cancer – a Phase I/II study  in combination with Keytruda and a Phase I study as monotherapy in neoadjuvant (pre-operative) treatment. The study of Blautix is expected to recruit up to 500 patients and will evaluate the efficacy and safety in IBS with constipation (IBS-C) and/or IBS with diarrhoea (IBS-D) over eight weeks. The primary endpoint will be the Overall Response rate, defined as the proportion of patients reporting an improvement in their weekly cohort-specific symptoms (abdominal pain and stool frequency or consistency) for at least four out of eight weeks. A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.

This study is open-label and will recruit up to 132 patients with metastatic cancer across multiple cancer types (non-small cell lung cancer, renal cell carcinoma, bladder cancer and melanoma) who have failed prior anti-PD-1 therapy.  Part A of the study will enrol 12 patients with the primary outcome measure to assess safety and tolerability. Patients will continue on therapy with follow-up assessments including the anti-tumour effect of the combination. Recruitment is progressing as expected and we anticipate completing Part A before the end of 2019.  At this point, Part B of the study, which has a primary endpoint to assess the clinical benefit of the combination, will commence.

4D Pharma, whose market capitalisation is £62m, is a key holding of the troubled investment manager, Woodford Asset Management, which owns a 24% stake (having confirmed the sale of 3% today). 4D Pharma held cash and equivalents of £26.2m as of 31 December.

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