Long term follow-up data for MaaT 013 in early access program for patients with aGvHD to be presented at the upcoming EBMT conference
MaaT Pharma will present extended results from its Early Access Program for patients with aGvHD that were treated with MaaT 013 and, for the first time, Overall Survival data after 12 months in more patients
The data will be shared during an oral presentation at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation held in Glasgow, UK, from April 14-17, 2024. Details from the presentation will be disclosed in a press release on April 17th, 2024, in compliance with the conference embargo policy.
Aligned with its mission to enhance the survival of cancer patients, MaaT Pharma has been actively involved in the EAP in Europe since 2019. The Company has consistently presented real-world data from its EAP at major hematology conferences over the past four years. At each data communication point, EAP results confirm previous findings, that MaaT 013 has an impact on overall survival (OS) when the primary endpoint (gastrointestinal Overall Response Rate at D28) is achieved. To date, over 220 patients have been treated with MaaT 013 in Europe in clinical trials and the EAP.
In the context of the EAP, the Company has bolstered its manufacturing & supply chain, ensuring timely and safe provision of MaaT013 to 38 stem cell transplant hospitals across 6 European countries: Austria, Belgium, France, Germany, Italy, and Spain.
Dr. Michael Loschi, hematologist at Nice Hospital in France emphasized “we are enrolling in the EAP due to the lack of third-line treatment options for patients with aGvHD who are unresponsive to corticosteroids and ruxolitinib. We receive MaaT 013 within 48 hours following the request via a simple procedure for EAP. This has transformed our routine to treating patients with aGvHD and significantly improved their quality of life. The data presented at ASH align with our observations in clinical practice. We’ve observed superior efficacy with more complete responses in gastrointestinal aGvHD and less toxicity when compared to other immune suppressive drugs. “
“I find the procedure in EAP to be quite straightforward” shared Dr. Alexander Schauwvlieghe, hematologist at AZ Sint-Jan Brugge AV Hospital in Belgium. “I’m a strong advocate for gut microbiome-based treatments, such as MaaT 013, that prioritize immune restoration in GvHD. This approach helps maintain the patient’s immune function, reducing the risk of infectious complications and relapse.”
A pivotal Phase III trial (n=75) evaluating MaaT 013 (ARES trial – NCT04769895) in patients with corticosteroid and ruxolitinib-refractory gastrointestinal aGvHD is currently ongoing to confirm the results from the EAP. The Company previously shared the positive review by DSMB for the Phase III ARES trial, including a favorable benefit/risk ratio, with “high efficacy and low toxicity.”
Details of Oral Presentation at EBMT 2024: Title: "Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe". Abstract number: OS13-07 Session: OS13 Oral Session 13 | GVHD. Session Date/Time: Wednesday, April 17, 10:30 – 11:45.
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