4D pharma Presents Microbiome Analyses from Phase II Clinical Trial of Blautix® for IBS-C and IBS-D at Gastro 2021

Rhea-AI Summary

4D pharma plc, a leader in Live Biotherapeutics, announced new findings from the Phase II trial of Blautix^® for irritable bowel syndrome (IBS-C and IBS-D). The trial included 353 patients, showing significant gut microbiome changes post-treatment, with Blautix outperforming placebo. These findings highlight Blautix's potential as a novel treatment option for IBS, addressing unmet medical needs worldwide. The company awaits FDA feedback regarding further development strategies for Blautix amidst ongoing review delays due to COVID-19.

Positive

• Blautix demonstrated significant changes in gut microbiome structure in IBS patients.
• Blautix treatment showed improvements in microbiota interconnectivity.
• The trial involved a robust sample size of 353 patients.

Negative

• Delays in FDA review processes due to COVID-19 may hinder development timelines.
• Company continues to await FDA feedback which is crucial for progressing Blautix.

Results demonstrate changes in gut microbiome structure following administration of Blautix in both IBS-C and IBS-D patients

LEEDS, England--(BUSINESS WIRE)-- 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces new fecal microbiome analyses from the completed Phase II trial of Blautix^® (MRx1234) as a treatment for irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D). The new data will be presented in an ePoster at Gastro 2021, held from December 9-11, 2021.

The Phase II study was a multicenter, randomized, double-blind trial that enrolled 353 patients with IBS-C or IBS-D. Patients were treated for eight weeks with either Blautix or placebo. Microbiome composition and microbial co-occurrence network analyses were performed on 949 fecal samples from 260 subjects from the four study treatment groups (IBS-C Blautix-treated, IBS-C placebo-treated, IBS-D Blautix-treated, IBS-D placebo-treated) at baseline (week 0), mid-treatment (week 4), end of treatment (week 8), and wash-out (week 12).

Treatment with Blautix led to structural changes in the gut microbiota of patients with both IBS-C or IBS-D. These changes did not occur in placebo treatment groups. Blautix treatment led to greater increases in interconnectivity between taxa than in the placebo-treated group, also in both IBS-C and IBS-D cohorts. Blautix (Blautia hydrogenotrophica) was associated with a subnetwork of multiple taxa showing high connectivity and ultimately impacting the overall microbiome structure, also in both IBS-C and IBS-D patients.

4D pharma previously announced positive initial topline results from the Phase II trial in October 2020 and presented further positive results of additional post-hoc analyses at Digestive Disease Week (DDW) in May 2021. The Gastro 2021 presentation is available via the Posters & Presentations area of the 4D pharma website at www.4dpharmaplc.com.

“The additional microbiome analyses from the Phase II study represent an interesting and important finding, further establishing the mechanisms through which Blautix exerts its beneficial effects in both IBS-C and IBS-D. The results show that administration of a single strain Live Biotherapeutic can have significant positive effects on the composition and structure of the microbiome in these patients,” said Prof. Eamonn Quigley, Head of Gastroenterology and Hepatology at Houston Methodist Hospital and the Study’s Chief Investigator. “As a result, Blautix is an exciting novel treatment option for IBS patients. Its activity across multiple subtypes, further demonstrated with today’s data, is particularly remarkable.”

“These microbiome analyses are an important addition to our already significant clinical data package for Blautix. These findings from the Phase II trial, coupled with the positive outcomes of the previous post-hoc analysis, demonstrate that Blautix could provide a significant solution to address the high unmet needs of millions of patients globally with IBS,” said Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. “Our complimentary MicroRx and MicroDx platforms enable this level of detail regarding the mechanism of action of Blautix, along with those of 4D pharma’s pipeline of other Live Biotherapeutics across multiple indications. We continue to await feedback from the FDA which will inform our strategy for progressing Blautix as a novel treatment option for IBS patients in need.”

The US Food and Drug Administration (FDA) has updated 4D pharma regarding ongoing substantial delays to its review processes as a result of the COVID-19 pandemic. As a result 4D pharma continues to await feedback from the FDA regarding the results of its Phase II study of Blautix for the treatment of IBS and the Company’s questions ahead of progression into any pivotal program.

About the Blautix^® Phase II clinical trial

The Blautix^® Phase II clinical trial (ClinicalTrials.gov identifier: NCT03721107) is a multicenter, randomized, placebo-controlled study that enrolled a total of 353 patients with IBS-C or IBS-D with eligible baseline data (158 and 195 patients, respectively). Patients in each cohort were randomized 1:1 to receive either Blautix or placebo; in total, 76 IBS-C patients and 94 IBS-D patients received Blautix treatment. Blautix or placebo was administered orally as two capsules, twice daily for eight weeks.

About Blautix^®

Blautix^® is a single strain Live Biotherapeutic product (LBP), being developed as a treatment for both IBS-C and IBS-D. Pre-clinical studies demonstrated its ability to address visceral hypersensitivity and other symptoms of IBS and increase microbiome diversity. A Phase I study in healthy volunteers and IBS patients showed that Blautix was well tolerated and an improvement in symptoms was also reported relative to placebo. The Phase II BHT-II-002 trial demonstrated an impact on overall response with regard to bowel habit and abdominal pain in IBS-C and IBS-D. Blautix was well tolerated, with a safety profile comparable to placebo.

About 4D pharma

4D pharma 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 bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx^®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.

4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has five clinical programs, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix^® in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

For more information, refer to https://www.4dpharmaplc.com

Forward-Looking Statements

This announcement contains "forward-looking statements." All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding the efficacy of Live Biotherapeutics including Blautix^®, its ability to impact the treatment of irritable bowel syndrome, regulatory interactions, and the utility of the MicroRx^® and MicroDx^® platforms are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified by the words "believe," "expect," "anticipate," "plan," "intend," "foresee," "should," "would," "could," "may," "estimate," "outlook" and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.

All of the Company's forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control, and assumptions that could cause actual results to differ materially from the Company's historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that affect the Company's business, including the risks relating to the activity and efficacy of its Live Biotherapeutic drug candidates including Blautix, interactions with regulatory bodies including the US FDA, and those additional risks and uncertainties described the documents filed by the Company with the US Securities and Exchange Commission ("SEC"), should be carefully considered. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of its forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211209005169/en/

4D pharma

Investor Relations: ir@4dpharmaplc.com

Singer Capital Markets - Nominated Adviser and Joint Broker +44 (0)20 7496 3000

Philip Davies / James Fischer (Corporate Finance)

Tom Salvesen (Corporate Broking)

Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500

Dominic Wilson / Phil Walker

Stern Investor Relations, Inc. +1-212-362-1200

Julie Seidel Julie.seidel@sternir.com

Image Box Communications +44 (0)20 8943 4685

Neil Hunter / Michelle Boxall

neil@ibcomms.agency / michelle@ibcomms.agency

6 Degrees

Lynne Dardanell +1-336-202-9689

ldardanell@6degreespr.com

Source: 4D pharma plc

FAQ

What were the results of the Phase II trial for LBPS?

The Phase II trial showed that Blautix caused significant changes in the gut microbiome of IBS patients, indicating its effectiveness.

How many patients were involved in the Blautix Phase II trial?

The trial enrolled a total of 353 patients with IBS-C and IBS-D.

What is the significance of the microbiome changes observed in the trial?

These changes suggest Blautix effectively alters gut microbiota, which could lead to improvements in IBS symptoms.

When will 4D pharma receive feedback from the FDA regarding Blautix?

4D pharma is currently awaiting FDA feedback, but there are delays due to the COVID-19 pandemic.

What is the next step for Blautix after the Phase II trial?

The next step involves awaiting FDA feedback to inform strategies for progressing Blautix into pivotal programs.