MaaT Pharma To Present Updated Data for MaaT013 in Early Access Program at the European Hematology Association (EHA) Annual Congress
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 updated data from its Early Access Program for 173 patients with aGvHD treated with MaaT013 have been selected for oral presentation at the European Hematology Association (EHA) Annual congress, taking place in Milan from June 12–15, 2025. The oral presentation of MaaT013 data at EHA—Europe's leading hematology conference—underlines the growing recognition of the drug's clinical potential and the Company's leadership in hemato-oncology using microbiome-based approach.
These updated EAP results for 173 patients, to be presented at EHA Congress, are consistent with the positive topline results of the Phase 3 trial announced in January 2025 and further confirm MaaT013's high efficacy and favorable safety profile in treating patients with gastrointestinal aGvHD. There are currently no approved options for patients with GI-aGvHD who are refractory to steroids and either refractory or intolerant to ruxolitinib, despite the poor prognosis with one-year survival rates of 15% (Abedin et al., 2021).
MaaT Pharma has observed a 75% increase in physician demand with MaaT013 under the ongoing EAP in 2024 compared to 2023, across Europe and, more recently, in the United States. This steady demand for access to MaaT013 reflects its growing adoption by the medical community as a treatment option for patients with GI-aGvHD. To date, the Company has safely treated more than 300 patients with aGvHD across clinical trials and the Company's EAP ongoing in both Europe and the U.S.
With upcoming regulatory milestones in Europe including a Marketing Authorization submission expected in June 2025, growing global physician interest, and continued clinical validation, MaaT013 has the potential to become the first approved third-line treatment for GI-aGvHD, significantly improving survival outcomes for approximately 3,000 third-line patients annually across the U.S., Canada, and Europe.
Details of the Oral Presentation:
Title: Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe
Abstract number: S260
Presenting Author: Mohamad Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University
Session title: s424 Stem cell transplantation - Session 2
Date & Time: 13/06/2025 (17:00 - 18:15 CEST) - Brown Hall 3
MaaT Pharma will also present its ongoing Phase 2b trial (PHOEBUS) design for MaaT033 developed as an adjunctive therapy 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. To date, the independent Data Safety Monitoring Board (DSMB) has conducted two safety reviews and one unblinded interim analysis, all of which concluded positively with the recommendation that the PHOEBUS trial proceed as planned.
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.
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