MaaT Pharma, a clinical-stage biotechnology company specializing in Microbiome Ecosystem Therapies™ (MET) to improve cancer patient survival, announced the first treatment in the United States of a patient with acute Graft-versus-Host Disease (aGvHD) under the FDA’s Single Patient Expanded Access program. This program allows patients with serious or life-threatening conditions to access investigational treatments outside of clinical trials when no alternative options are available. The patient, who had previously undergone several therapies including steroids and ruxolitinib, received treatment at City of Hope, a leading cancer research institution in Los Angeles.
The treatment was administered by Dr. Monzr M. Al Malki and Dr. Ryotaro Nakamura, both experts in Hematopoietic Cell Transplantation and GvHD. Dr. Nakamura expressed enthusiasm about the potential of MaaT013 to address refractory aGvHD, while Dr. Al Malki highlighted the promise of microbiome-based immune modulation for improving aGvHD outcomes.
Hervé Affagard, CEO and co-founder of MaaT Pharma, emphasized the urgent need for innovative treatments for refractory aGvHD, noting that MaaT013 is gaining international recognition as a potential breakthrough for patients facing this life-threatening condition.
MaaT Pharma is advancing the Phase 3 ARES trial in Europe, with patient recruitment now complete and topline results expected in January 2025. The company is also preparing to initiate a U.S. Phase 3 clinical trial to evaluate MaaT013 in aGvHD patients with gastrointestinal involvement. Clinical batches of MaaT013 have been distributed for expanded access under FDA oversight. Additionally, data from the Early Access Program in Europe will be presented at the ASH 2024 Annual Meeting in December.
About MaaT Pharma
MaaT Pharma is a late-stage clinical company focused on developing gut microbiome-driven therapies to modulate the immune system and improve cancer patient survival. Founded in 2014 and based in Lyon, France, the company is a pioneer in microbiome-based immunomodulation in oncology. MaaT Pharma has been listed on Euronext Paris since 2021.
About MaaT013
MaaT013 is an off-the-shelf, standardized, pooled-donor Microbiome Ecosystem Therapy™ designed to treat aGvHD in hospitalized patients. It restores the gut microbiome’s symbiotic relationship with the immune system, improving immune function and reducing steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has received Orphan Drug Designation from both the FDA and EMA.
