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MaaT Pharma Presents Updated Positive Data in Early Access Program for Xervyteg® at the EHA Congress Validating High Efficacy Observed in Pivotal ARES Study in Acute Graft-versus-Host Disease
LYON, France, June 13, 2025--MaaT Pharma Presents Updated Positive Data in Early Access Program for Xervyteg® at the EHA Annual Congress.
About this update from Maat Pharma
LYON, France, June 13, 2025 --( BUSINESS WIRE )--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Professor Mohamad Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University, will present updated data for Xervyteg ® (MaaT013) in treating acute Graft-versus-Host Disease (aGvHD) under the Early Access Program (EAP) at the European Hematology Association (EHA) Annual Congress 2025. This independent EAP dataset further supports the efficacy and safety profile of Xervyteg ® previously shown in the pivotal ARES trial . It also confirms the breakthrough potential of Xervyteg ® for aGvHD patients with limited treatment options and it also serves as supportive data within the Marketing Authorization Application (MAA) recently submitted to the European Medicines Agency (EMA). Key highlights: A subset of patients (n=70) failing both steroid resistant (SR) and ruxolitinib resistant (RR) and thus resembling the cohort enrolled in the pivotal Phase 3 ARES trial ( NCT04769895 ), exhibited a significant and consistent efficacy profile: The complete data may be found here . "The consistency between the real-world Early Access Program data and our pivotal ARES trial underscores Xervyteg ® ’s clinical benefit for patients with severe, treatment-resistant aGvHD," said Dr. Gianfranco Pittari, PhD, Chief Medical Officer at MaaT Pharma . "This is particularly meaningful for clinicians and patients, as it confirms the potential of microbiome therapies to deliver long-term survival benefits in a population with historically poor outcomes." In comparison, historical data from Abedin et al. 2021 demonstrated that in a similar population of patients, i.e. third-line aGvHD patients receiving additional treatment after ruxolitinib failure, the median survival was only 28 days. "Among patients who responded by Day 28, the majority achieved a complete resolution of aGvHD symptoms — a strong predictor of sustained disease control over time. The overall safety profile is favorable in this high-risk patient population," outlines Professor Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University. Details of the Oral Presentation: MaaT Pharma also presented a poster on the design of its ongoing Phase 2b trial (PHOEBUS) evaluating MaaT033 to enhance overall survival in allo-HSCT. This international, multi-center trial ( NCT05762211 ) is the largest randomized controlled study to date of a microbiome-based therapy in oncology, enrolling up to 387 patients across 60 sites. --- About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "aim", "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. * France, Austria, Belgium, Canada, Germany, Italy, Lebanon, Spain, Sweden, Switzerland & USA View source version on businesswire.com: https://www.businesswire.com/news/home/20250612786488/en/ Contacts MaaT Pharma – Investor Relations Guilhaume DEBROAS, Ph.D. Head of Investor Relations +33 6 16 48 92 50 [email protected] Rx Communications Group – U.S. Investor Relations Michael Miller Managing Director +1-917-633-6086 [email protected] MaaT Pharma – Media Relations Pauline RICHAUD Senior PR & Corporate Communications Manager +33 6 14 06 45 92 [email protected] Catalytic Agency – U.S. Media Relations Heather Shea Media relations for MaaT Pharma +1 617-286-2013 [email protected]