Overview of the Updated Data Presentation

MaaT Pharma, a clinical-stage biotechnology company pioneering Microbiome Ecosystem Therapies™, presented encouraging updated clinical data for Xervyteg® (MaaT013) in the Early Access Program (EAP) treatment of acute Graft-versus-Host Disease (aGvHD). The data was shared at the European Hematology Association (EHA) annual congress, with an oral presentation by Professor Mohamad Mohty, Head of Hematology and Cellular Therapy at Saint-Antoine Hospital, Sorbonne University.

Clinical Significance of Early Access Program Data

The EAP provided real-world evidence on 173 patients across 11 countries with steroid and ruxolitinib-refractory aGvHD treated with MaaT Pharma’s microbiome therapy. These data complement the pivotal Phase 3 ARES trial results submitted to the European Medicines Agency (EMA) in early June 2025. Patients showed high overall response rates and durable survival benefits, with a favorable safety profile, confirming the therapeutic potential in a population with very limited options.

Mechanism and Therapeutic Rationale

Xervyteg® is an oral microbiome ecosystem therapy designed to restore gut microbiome diversity and functionality. Its mechanism is based on immune system modulation by correcting dysbiosis, a known contributor to GvHD pathogenesis. By realigning gut flora, the therapy reduces inflammation and improves immune tolerance post hematopoietic stem cell transplantation.

Regulatory and Market Implications

The reinforced dataset enhances MaaT Pharma’s Marketing Authorization Application, positioning Xervyteg® to address a critical unmet need in hematology and transplant medicine. The EAP’s broad geographic reach underlines global interest and potential market penetration.

Ongoing and Future Clinical Development

MaaT Pharma continues to support wider EAP access while preparing for regulatory review and potential commercialization in Europe. Further studies are underway exploring microbiome therapies in oncology and immune diseases, expanding the company’s pipeline.