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Business Upturn
a day ago
- Business
- Business Upturn
Live Biotherapeutics at a Crossroad: Novotech White Paper Outlines Opportunities and Early-Stage Challenges
Sydney, Australia: As Live Biotherapeutic Products (LBPs) begin to transition from frontier science to clinical reality, Novotech, a leading global CRO and scientific advisory partner has published a new white paper examining the opportunities and challenges shaping this fast-evolving landscape of therapeutic class. This press release features multimedia. View the full release here: LBPs, which harness live microorganisms to restore or modulate human health, are being explored across a growing range of indications, from gastrointestinal and metabolic disorders to CNS and oncology. FDA approvals of Rebyota™ and Vowst™ have validated the category but for most biotech sponsors, the journey remains uncertain. According to Novotech's analysis, over 90% of LBP assets are still in early development stages, and nearly one-third of all trials from 2020 to 2025 have been withdrawn or suspended due to regulatory, manufacturing, or design complexities. Highlights from the report include: A growing pipeline of preclinical and Phase I–II LBP candidates, with notable concentration in Alzheimer's, IBD, diabetes, and NASH. Over 90 industry-sponsored trials launched since 2020, yet 32% have experienced discontinuation. North America and Europe leading in regulatory approvals and manufacturing activity, with rising interest from biotechs in Asia-Pacific. A projected CAGR of 38% for the LBP and microbiome CDMO market through 2030. The global market for LBPs and microbiome contract development and manufacturing organizations (CDMOs) was valued at USD 31.84 million in 2023. With growing investment in players like Vedanta Biosciences and MaaT Pharma, the LBP field is maturing but also becoming more competitive. Success will depend on smart trial design, global regulatory navigation, and efficient feasibility execution. Drawing on deep therapeutic expertise in microbiome-related studies and gastrointestinal, metabolic, and immunologic indications, Novotech supports sponsors from early development through global trial delivery. With operations spanning Asia-Pacific, North America, and Europe, Novotech is uniquely positioned to help biotech and small to mid-size pharma companies translate LBP potential into clinical success. Download the full white paper 'Why Live Biotherapeutics Matter to Emerging Biotech' here. For further information, please visit About Novotech Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase. With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results. For more information or to speak to an expert team member visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
05-06-2025
- Business
- Yahoo
$1.2 bN Human Microbiome-based Drugs and Diagnostics Global Markets, 2022-2024 & 2025-2030
The human microbiome-based drugs and diagnostics market is projected to grow from $393.4M in 2025 to $1.2B by 2030, at a CAGR of 25.6%. Key players include Ferring, Nestlé Health Science, and Vedanta Biosciences. The report covers market trends, competitive landscape, and ESG developments. Dublin, June 05, 2025 (GLOBE NEWSWIRE) -- The "Human Microbiome-based Drugs and Diagnostics: Global Markets" report has been added to global market for human microbiome-based drugs and diagnostics is expected to grow from $393.4 million in 2025 to reach $1.2 billion by the end of 2030, at a compound annual growth rate (CAGR) of 25.6% from 2025 through 2030. The report discusses emerging technologies and analyzes the competitive landscape, providing the ranking/market shares of leading companies in the market. It also includes a chapter on environmental, social and corporate governance (ESG) microbiome-based drugs and diagnostics are novel approaches to tackling difficult-to-treat diseases. The growing understanding of the human microbiome can be leveraged to fill the gaps in conventional treatment options. A wide range of scientific studies have demonstrated the role of microbiomes in the pathogenesis of various diseases. The microbiome field is also witnessing an increased level of investments from the private and public sectors. Future opportunities in the market lie in exploring microbiomes in other body parts, such as lungs, and developing microbiome-based drugs as combination therapies. Leading companies in the market for human microbiome-based drugs and diagnostics include Ferring, Nestle Health Science (Seres Therapeutics), BiomeBank, Genetic Analysis AS and Vedanta Scope 55 data tables and 51 additional tables Analyses of the trends in global markets for human microbiome-based drugs and diagnostics, with revenue data from 2022 to 2024, estimates for 2025, and projected CAGRs through 2030 Estimates of the size and revenue prospects for the global market, along with a market share analysis by type, drug route of administration, diagnostics product type, application, end user, and region Facts and figures pertaining to market dynamics, opportunities and deterrents, technological advances, regulations, and the impacts of macroeconomic variables Review of the prevalence of infectious diseases, metabolic disorders and chronic ailments An assessment of current products, clinical trials and identification of new potential markets for novel products and assay development Overview of the sustainability trends and ESG developments in the industry, with emphasis on the ESG practices followed by leading companies, their ESG ratings, and consumer attitudes An analysis of the key patent grants and recently published patents Analysis of the industry structure and value chain, and the competitive landscape, including companies' market shares, strategic alliances, M&A activity, venture fundings and investment outlook Profiles of the leading companies, including Ferring Pharmaceuticals, Nestle Health Science, BiomeBank, Genetic Analysis AS, and Vedanta Biosciences Inc. Companies Featured BiomeBank EnteroBiotix Ltd. Enterome Ferring Genetic Analysis Illumina Inc. Microbiome Insights Microbiotica Nestle Health Science Oxford Nanopore Technologies plc PacBio SFA Therapeutics Inc. Thermo Fisher Scientific Inc. Vedanta Biosciences Inc. Key Topics Covered: Chapter 1 Executive Summary Market Outlook Scope of Report Market Summary Market Dynamics Emerging Technologies Analysis by Segment Regional Analysis Conclusion Chapter 2 Market Overview Overview and Market Definition Different Microbiomes in Humans Microbiome, Human Health and Disease Technologies Aiding Microbiome Research Culturing and Cultivation Strategies for the Development of Microbiome Therapeutics Additive Microbiome Therapy Modulatory Microbiome Therapy Analysis of Macroeconomic Factors Geopolitical Factors Inflation and Currency Exchange Fluctuations Porter's Five Forces Analysis Chapter 3 Market Dynamics Takeaways Market Drivers Growing Evidence of Microbiome-disease Correlation Microbiome-based Diagnostics for Disease Prevention and Monitoring Market Restraints Challenges in Clinical Trial Design Lack of Established Regulatory Frameworks High Costs of Microbiome Therapeutics Market Opportunities Direct-to-Consumer Microbiome Testing Drugs and Diagnostics for Lung and Skin Microbiomes Chapter 4 Regulatory Landscape Regulatory Aspects North America Europe Asia-Pacific Chapter 5 Emerging Technologies Takeaways Emerging Technologies Microbial Ecosystem Therapeutics Metatranscriptome Sequencing Genetically Modified Microbiome Therapeutics Combination and Adjuvant Therapies with Microbiome-based Drugs Novel Preclinical Models Chapter 6 Market Segmentation Analysis Segmentation Breakdown Market Analysis by Type Microbiome-based Drugs Market Analysis by Application Infectious Diseases GI Disorders Metabolic Disorders Cancer Other Diseases Market Analysis by End User Hospitals and Clinics Research Institutions Pharmaceutical Companies Geographic Breakdown Market Analysis by Region North America Europe Asia-Pacific South America Middle East and Africa Chapter 7 Competitive Intelligence Takeaways Company Share Analysis Competitive Analysis Venture Funding and Investment Landscape Recent Developments Chapter 8 Sustainability in the Human Microbiome-based Drugs and Diagnostics Industry: An ESG Perspective Introduction to ESG ESG Risk Ratings Concluding Remarks Chapter 9 Appendix For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Associated Press
27-01-2025
- Business
- Associated Press
PureTech Founded Vedanta Biosciences Publishes Additional Phase 2 VE303 Results in Nature Medicine
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ('PureTech' or the 'Company'), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity, Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies for gastrointestinal diseases, today announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI). The new analyses were published this month in Nature Medicine and can be viewed online. VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of rCDI, which consists of a defined consortium of eight bacterial strains. Clinical results from Vedanta's successful Phase 2 CONSORTIUM study, published in the Journal of the American Medical Association (JAMA), demonstrated that the higher dose of VE303 studied was well tolerated and reduced the odds of CDI recurrence by more than 80% compared with placebo. The new publication which is entitled 'Multi-omic Profiling a Defined Bacterial Consortium for Treatment of Recurrent Clostridioides difficile Infection,' reports additional results from CONSORTIUM. Profiling of microbiome composition, fecal metabolites, and host immune function indicated that VE303 works through multiple mechanisms to prevent rCDI by restoring a healthy gut microbial community, decreasing inflammation, and increasing levels of protective metabolites. In addition, the work identified predictors of high or low VE303 colonization and clinical response. Taken together, these results demonstrate that VE303 works through multiple mechanisms to reduce CDI recurrence. Results from the CONSORTIUM study informed the design and dose selection for the global, pivotal Phase 3 study, RESTORATiVE303, that is currently underway to confirm the efficacy and safety profile of VE303 in the prevention of rCDI. Topline data for this study are expected in 2026. The full text of the announcement from Vedanta is as follows: Vedanta Biosciences Publishes Additional Phase 2 VE303 Results in Nature Medicine VE303 was well tolerated and decreased the odds of rCDI through multiple mechanisms Analyses identified predictors of VE303 colonization and protection from CDI recurrence Topline data for the ongoing Phase 3 pivotal RESTORATiVE303 study are expected in 2026 CAMBRIDGE, Mass., January 23, 2025 -- Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies for gastrointestinal diseases, today announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI). The new analyses were published this month in Nature Medicine and can be viewed online. VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of rCDI, which consists of a defined consortium of eight bacterial strains. Clinical results from Vedanta's successful Phase 2 CONSORTIUM study, published in the Journal of the American Medical Association (JAMA), demonstrated that the higher dose of VE303 studied was well tolerated and reduced the odds of CDI recurrence by more than 80% compared with placebo. VE303 organisms rapidly and robustly colonize the gut in a dose-dependent manner. Colonization predicted greater recurrence-free probability, establishing a direct connection between exposure and clinical response. The publication which is entitled 'Multi-omic Profiling a Defined Bacterial Consortium for Treatment of Recurrent Clostridioides difficile Infection,' reports additional results from CONSORTIUM. Profiling of microbiome composition, fecal metabolites, and host immune function indicated that VE303 works through multiple mechanisms to prevent rCDI by restoring a healthy gut microbial community, decreasing inflammation, and increasing levels of protective metabolites. In addition, the work identified predictors of high or low VE303 colonization and clinical response. 'This clinical research offers new insights into the mechanisms of action of VE303, providing a rationale for the drug's protective effects in rCDI,' said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. 'Due to VE303's precisely known, defined composition, we can study its mechanisms of action and PK-PD relationships in a rigorous way, taking a step towards understanding why some patients respond better than others to a microbiome restoration intervention. We believe this line of work helps fill a knowledge gap in the field, since characterization of the mechanisms of action of first-generation fecal microbiota products has been very limited.' Highlights of the publication include: Abundance of specific VE303 strains, and of VE303 strains overall, was predictive of remaining recurrence-free. The strains that colonized well differed across individuals, suggesting that efficacy is derived from strains working together as a consortium. VE303 colonization and clinical benefit correlated with increased levels of short-chain fatty acids and key secondary bile acids, both of which have beneficial effects in conferring resistance to CDI. Faster recovery of a more diverse microbiome, which was seen in the high dose recipients of VE303, was associated with non-recurrence. The elimination rate of the antibiotic used for the CDI episode was a predictor of VE303 colonization. Given that clearance of residual antibiotic from stool varies significantly among individuals and can take a week or longer, treating with VE303 for 14 consecutive days following completion of standard-of-care antibiotics enabled VE303 strains to be inoculated when the intestinal environment was most permissive to colonization. VE303 use led to lower levels of pro-inflammatory and potentially pathogenic Gram-negative species, including Klebsiella and Citrobacter, that are linked to CDI recurrence and AMR bacterial infections. Taken together, these results demonstrate that VE303 works through multiple mechanisms to reduce CDI recurrence. Results from the CONSORTIUM study informed the design and dose selection for the global, pivotal Phase 3 study, RESTORATiVE303, that is currently underway to confirm the efficacy and safety profile of VE303 in the prevention of rCDI. Topline data for this study are expected in 2026. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00177. About VE303 VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of recurrent Clostridioides difficile infection (rCDI). VE303 is an orally administered, defined bacterial consortium therapeutic candidate which consists of eight strains that were rationally selected using Vedanta's product engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta published positive results in JAMA in April 2023 from the Phase 2 CONSORTIUM trial, in which VE303 met its primary endpoint of preventing C. difficile infection recurrence at eight weeks. Vedanta is currently enrolling patients into a Phase 3 RESTORATiVE303 registrational study of VE303 for the prevention of recurrent C. difficile infection. Vedanta Biosciences received a $5.4 million research grant from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) in 2017 and a contract of up to $81.9 million from Biomedical Advanced Research and Development Authority (BARDA) in 2020 to support clinical studies of VE303. VE303 was granted Orphan Drug Designation in 2017 by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent CDI. About Vedanta Biosciences Vedanta Biosciences is a clinical-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets are potential first-in-class oral therapies – VE303, in a Phase 3 registrational trial for prevention of recurrent C. difficile infection, and VE202, in a Phase 2 trial for treatment of ulcerative colitis. Vedanta's pipeline has been built using the company's industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by broad foundational intellectual property, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale. About PureTech Health PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit or connect with us on X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to Vedanta's development plans for its pipeline of therapeutics of defined bacterial consortia as oral therapies for gastrointestinal diseases, including VE303, the timing of topline results for ongoing clinical trials, potential benefits to patients, and Vedanta's and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption 'Risk Factors' in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Public Relations [email protected] [email protected] /EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 [email protected] Media Justin Chen +1 609 578 7230 [email protected] KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: HEALTH GENERAL HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: PureTech Health plc Copyright Business Wire 2025. PUB: 01/27/2025 02:00 AM/DISC: 01/27/2025 02:00 AM
