MaaT Pharma: Multicenter Study Reinforces the Value of MaaT013 After Ruxolitinib Failure
MaaT Pharma announces the publication of the CHRONOS study, a multicenter retrospective analysis evaluating third-line treatments in 59 patients with refractory gastrointestinal graft-versus-host disease. Presented at the 2026 EBMT annual congress and published in Bone Marrow Transplantation, the study aims to contextualize the results of its drug candidate MaaT013 (Xervyteg®) in its application for authorization from the European Medicines Agency.
Overview of the CHRONOS Study
The CHRONOS study retrospectively assessed 59 adult patients treated in 16 transplantation centers located in Austria, Belgium, France, and Spain, where first-line (corticosteroids) and second-line (ruxolitinib) treatments had failed. The majority of patients had severe disease, with 46% at grade III and 48% at grade IV, and were resistant to corticosteroids (97%) and ruxolitinib (95%). Twelve third-line systemic therapies were used, including anti-TNF-alpha, extracorporeal photopheresis, and vedolizumab. The results showed a 37% overall gastrointestinal response rate at day 28, consisting of 22% complete responses, 10% very good partial responses, and 5% partial responses. However, response rates rapidly decreased by day 56 (22% for gastrointestinal response), and the overall survival at 12 months was 29%, with a median survival of 86 days. These findings highlight the poor prognosis for patients after ruxolitinib failure and the ongoing lack of therapeutic standardization.
Contextualizing MaaT013's Role in Third-Line Treatment
MaaT Pharma sponsored the CHRONOS study to contextualize the results of its pivotal ARES study evaluating MaaT013 (Xervyteg®) and to support its Marketing Authorization Application to the EMA. This application is currently under evaluation, with a response expected by mid-2026, in line with standard timelines. The CHRONOS data provide a contemporary benchmark for managing gastrointestinal graft-versus-host disease in third-line treatment, highlighting the urgent need for new therapeutic options in this high-risk patient population.