MaaT Pharma Announces Phase 3 Study Results for Xervyteg
MaaT Pharma announced that the results of its Phase 3 study on the Xervyteg treatment will be presented at the ASH 2025 annual congress.
Presentation at the American Society of Hematology
According to the press release, MaaT Pharma will present the results of its pivotal Phase 3 study on Xervyteg (MaaT013) at the American Society of Hematology (ASH) in Orlando. The study focused on patients with steroid and ruxolitinib-refractory acute gastrointestinal graft-versus-host disease (aGvH). The data includes a 62% overall gastrointestinal response rate at day 28, with new information on secondary endpoints such as follow-up at day 56 and three months. The treatment is currently under evaluation by the European Medicines Agency, with a decision expected in the second half of 2026.
Results from the ARES Study
The ARES study, conducted across 50 centers in Europe, included 66 adult patients. Among them, 91% had a severe form of the disease. The overall response rates for all organs were 64%, with an estimated overall survival rate of 54% at 12 months. The data highlights a significant benefit for responders to the treatment at day 28, with a median survival not reached, contrasting with 54 days for non-responders.
Development of Microbiome-based Treatments
MaaT Pharma is developing treatments derived from the microbiome to modulate the immune system. Xervyteg was designed to treat severe dysbioses associated with aGvH disease. This treatment is the first immunomodulatory drug candidate based on the intestinal microbiota in oncology. According to the company, the product has received orphan drug designation from both the American and European agencies. The Xervyteg treatment continues its regulatory process with an application submitted to the EMA in June 2025.
