Irritable bowel syndrome (Blautix®)

We are currently conducting a Phase II study of Blautix in IBS-Constipation predominant (IBS-C) and IBS-Diarrhoea predominant (IBS-D) type patients in Europe and the USA.

A planned interim analysis demonstrated a safety profile comparable to placebo and non-futility in the primary endpoint.

Details of the study can be found here.


In 2016 we completed a Phase Ib study of Blautix, our live biotherapeutic candidate for irritable bowel syndrome (IBS).

The study met its primary objective of demonstrating that Blautix was safe and well tolerated. Encouragingly, we saw a greater proportion of Blautix-treated patients showing improvements in their IBS symptoms compared with patients receiving placebo. We also noted a greater proportion of the Blautix treatment group exhibiting a reduction in hydrogen breath levels – a biomarker of the drug’s activity. Analysis of patient samples using our proprietary microbiome profiling platform, MicroDx, showed that the administration of Blautix resulted in an increase in microbiome diversity.


Oncology (MRx0518)

4D’s MRx0518 is a live biotherapeutic candidate for cancer. We are investigating the effects of this candidate in a wide range of solid tumour types.


Phase I/II combination study

In collaboration with Merck & Co., known as MSD outside the United States and Canada, we are conducting a Phase I/II investigation of the combination of MRx0518 and Keytruda® (pembrolizumab) in patients with advanced or metastatic non-small cell lung cancer, kidney cancer, bladder cancer or melanoma who are refractory to prior anti-PD-1/PD-L1 therapy.

The trial is made up of two parts – Part A, an initial safety phase assessing dose-limiting toxicities after one three-week cycle of treatment in addition to clinical benefit, and the Part B cohort expansion phase. Part A was successfully completed in May 2020, and the safety review committee determined that it is safe to proceed to Part B of the study, which is ongoing. This study is being conducted at multiple sites in the United States.

Below is the clinical benefit analysis of all 12 patients enrolled in Part A (as of 21 August 2020):

RECIST 1.1 Response Criteria

Renal Cell Carcinoma

Non-Small Cell Lung Carcinoma

All Patients

N

9

3

12

Objective response rate (ORR)

2 (22%)

1 (33%) 1

3 (25%)

Stable disease (SD) ≥ 6 months

2 (22%)

0 (0%)

2 (17%)

Disease control rate

(response or SD ≥ 6 months)

4 (44%)

1 (33%)

5 (42%)

Progressive disease (PD)

5 (56%)

2 (67%)

7 (58%)

Details of the study can be found here.


Phase Ib monotherapy study

A Phase Ib study for patients with solid tumours that have received no prior treatment and are due to undergo surgical removal of the tumour is enrolling. This study is being conducted in London, UK.

Details of the study can be found here.


Phase I study in combination with radiotherapy

A Phase I study to evaluate the safety and preliminary clinical efficacy of MRx0518 in combination with preoperative radiotherapy in patients with resectable pancreatic cancer. The study is being conducted at The University of Texas MD Anderson Cancer Center and is the second opened as part of our strategic collaboration.

Details of the study can be found here.


Asthma (MRx-4DP0004)

We are currently conducting a Phase I/II clinical study of MRx-4DP0004 in patients with poorly controlled asthma. The study is taking place in Europe and the USA.

Details of the study can be found here.


COVID-19 (MRx-4DP0004)

4D is conducting a Phase II, randomised, double-blind, placebo-controlled trial in the UK, to evaluate the efficacy and safety of MRx-4DP0004 in hospitalised patients with COVID-19 (SARS-CoV-2 infection).

A short presentation summarising the data and scientific rationale supporting MRx-4DP0004 as an oral immunomodulatory therapeutic for COVID-19, can be found here.

The trial received expedited acceptance from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Details of the study can be found here.


If you would like more information on any of these studies, please e-mail clinicaltrials@4dpharmaplc.com


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