What's Happening?
MaaT Pharma has announced the results of its pivotal ARES Phase 3 trial for MaaT013 (Xervyteg®), a treatment for severe acute Graft-versus-Host Disease (aGvHD) with gastrointestinal involvement. The trial demonstrated a 54% one-year overall survival rate,
with significant gastrointestinal response rates at various checkpoints. The study involved 66 patients who were refractory to corticosteroids and ruxolitinib, showing a durable clinical benefit. MaaT013 is currently under regulatory review by the European Medicines Agency, with a decision expected in mid-2026.
Why It's Important?
The trial results are significant for patients with aGvHD, a condition with limited treatment options and poor prognosis. The high response rates and survival benefits observed in the trial suggest that MaaT013 could become a critical third-line therapy for aGvHD, addressing a significant unmet medical need. If approved, MaaT013 would be the first microbiotherapy in oncology, potentially setting a new standard for treating this challenging condition. The findings also highlight the potential of microbiome-based therapies in modulating immune responses and improving patient outcomes.
What's Next?
MaaT Pharma plans to submit the trial results for publication in a peer-reviewed medical journal. The company is also awaiting a regulatory decision from the European Medicines Agency, which could lead to the approval of MaaT013 as a new treatment option for aGvHD. If approved, MaaT013 would be the first microbiome-driven therapy in oncology, potentially paving the way for similar treatments in other immune-mediated conditions.
