Microbiome Disease Clinical Pipeline | 140+ Companies Advancing Next-Generation Therapies

The microbiome disease market is experiencing rapid growth and is driven by groundbreaking research and cutting-edge therapies. Industry leaders like MaaT Pharma, Qu Biologics, Biomica Ltd., and Seres Therapeutics are pioneering innovative treatment strategies, reshaping the landscape of microbiome-based therapeutics. As these transformative therapies progress through clinical development, they offer new hope for patients worldwide, redefining the future of microbiome disease management.

DelveInsight's 'Microbiome Disease Pipeline Insight 2025' report provides comprehensive global coverage of pipeline Microbiome Disease therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Microbiome Disease pipeline domain.

For emerging Microbiome Disease drugs, the Microbiome Disease pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Microbiome Disease Pipeline Report
• DelveInsight's Microbiome Disease Pipeline analysis depicts a robust space with 140+ active players working to develop 180+ pipeline drugs for Microbiome Disease treatment.
• The leading Microbiome Disease companies include MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc., Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc., and others are evaluating their lead assets to improve the Microbiome Disease treatment landscape.
• Key Microbiome Disease pipeline therapies in various stages of development include MaaT 013, QBKPN, BMC128, SER-155, MVT-201, and others.
• In April 2023, the FDA approved VOWSTTM (SER-109) from Seres and Nestlé to treat recurrent CDI, following the ECOSPOR trials. It is the first FDA-approved oral fecal microbiota product, containing bacterial spores purified from screened human donor feces.

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Microbiome Disease Overview
The microbiome is a diverse community of microorganisms that interact with the human body, playing a critical role in health and disease. These microbes, primarily bacteria and fungi, aid in digestion, protect against infections, and support essential physiological functions. However, some microbes can also be harmful, contributing to various diseases.

Studies have shown that the microbiome plays a significant role in metabolic disorders, particularly obesity and diabetes. Microbial imbalances can lead to insulin resistance, increased absorption of monosaccharides, elevated expression of lipogenic enzymes such as acetyl-CoA carboxylase and fatty acid synthase, enhanced triglyceride synthesis, and higher leptin levels, all of which contribute to metabolic dysfunction.

In inflammatory bowel diseases (IBD), microbiome alterations affect the host's metabolism and immune response. The inflammation seen in IBD can be triggered or worsened by genetic predisposition and environmental factors, such as diet. These changes in the gut microbiota can further impact disease progression, leading to chronic intestinal issues.

Emerging research has also linked the microbiome to cancer development, with studies demonstrating that microbial imbalances can promote tumor growth in organs such as the skin, colon, liver, breast, and lungs. Dysbiosis within the microbiome may influence cancer progression by affecting immune responses and metabolic pathways.

With a deeper understanding of the microbiome, personalized medicine is becoming a reality. Scientists are exploring ways to reprogram gut bacteria to restore microbial balance and treat diseases with minimal side effects. Since gut microbes naturally adapt to their environment, targeted modifications could provide precise and effective therapeutic solutions. This ability to tailor treatments based on microbial composition makes the microbiome a promising frontier in the future of medicine.

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Microbiome Disease Treatment Analysis: Drug Profile
MaaT013: MaaT Pharma
MaaT013 is a high-richness, high-diversity Microbiome Ecosystem TherapyTM designed to restore the balance between the gut microbiome and the immune system. It contains ButycoreTM, a consortium of bacterial genera known for producing immuno-regulatory metabolites that help modulate immune function and enhance tolerance. The therapy aims to reduce steroid-resistant, gastrointestinal-predominant acute Graft-versus-Host Disease (aGvHD) by improving immune responsiveness. MaaT013 has received Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is intended for acute hospital use as an off-the-shelf, multi-donor-derived therapy. The drug is currently in Phase III clinical development for the treatment of Graft-versus-Host Disease (GvHD).

QBKPN: Qu Biologics
QBKPN SSI is a first-in-class immune modulator developed to enhance the lungs' innate immunity and barrier function. The therapy is being evaluated in clinical trials for its potential to restore immune balance, prevent severe respiratory infections (including COVID-19 and its variants), and reduce all-cause mortality. Designed to strengthen the body's first line of defense against infections and immune-related diseases such as cancer, QBKPN SSI is positioned as a novel treatment approach for immunodeficiency disorders. The drug is currently in Phase II clinical development.

BMC128: Biomica Ltd.
BMC128 is a rationally-designed microbial consortium developed using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene's MicroBoost AI technology. As a Live Bacterial Product (LBP), BMC128 consists of four unique bacterial strains, naturally found in the human gut, with the ability to enhance immune responses and support anti-tumor activity through multiple biological mechanisms. Rationally-designed consortia like BMC128 aim to restore microbial diversity and functionality using individually selected, cultured bacteria. Currently, the drug is in Phase I clinical development for the treatment of colorectal cancer.

Key Microbiome Disease Therapies and Companies
• MaaT 013: MaaT Pharma
• QBKPN: Qu Biologics
• BMC128: Biomica Ltd.
• SER-155: Seres Therapeutics
• MVT-201: Micro Viable Therapeutics

Learn more about the novel and emerging Microbiome Disease pipeline therapies @ https://www.delveinsight.com/report-store/microbiome-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Microbiome Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Microbiome Disease Pipeline Report
• Coverage: Global
• Key Microbiome Disease Companies: MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc, Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc., and others.
• Key Microbiome Disease Pipeline Therapies: MaaT 013, QBKPN, BMC128, SER-155, MVT-201, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Microbiome Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Microbiome Disease Pipeline Therapeutics
6. Microbiome Disease Pipeline: Late-Stage Products (Phase III)
7. Microbiome Disease Pipeline: Late-Stage Products (Phase III)
8. Microbiome Disease Pipeline: Mid-Stage Products (Phase II)
9. Microbiome Disease Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.