MaaT Pharma will host a KOL webinar on December 17th, 2024, to discuss the data and the unmet medical need in acute Graft-versus-Host Disease (aGvHD) – Register here.
Key Results:
- Sustained High Response Rates at Day 28: Gastrointestinal Overall Response Rate (GI-ORR) was 51%, and Overall Response Rate (ORR) across all organs was 49%.
- Long-Term Survival: Overall Survival (OS) was 47% at 12 months and 42% at 24 months.
- Median OS for Responders: 444 days for those responding to MaaT013 in the ARES-like population, compared to 42 days for non-responders. Historical median OS following Ruxolitinib treatment is 28 days (Abedin et al., 2021).
- Topline ARES Phase 3 Trial Results Expected in January 2025.
MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotechnology company specializing in Microbiome Ecosystem Therapies™ (MET) for cancer survival through immune modulation, presented updated data at the 66th American Society of Hematology (ASH) Annual Meeting. The data covered 154 patients with acute Graft-versus-Host Disease (aGvHD) treated with MaaT013 through the Early Access Program (EAP) in Europe.
Dr. Florent Malard, MD, PhD, commented, “These results highlight MaaT013’s transformative potential for treating aGvHD, a condition with limited treatment options. The data further emphasize the role of gut microbiome modulation in improving survival outcomes in these patients.”
Hervé Affagard, CEO of MaaT Pharma, added, “Clinicians’ growing confidence in MaaT013, based on strong real-world data, boosts our expectations for the Phase 3 trial results. Success in aGvHD will be a significant step forward in demonstrating our microbiome-based therapies’ potential for treating complex immune diseases.”
Key Findings in the EAP Cohort (154 patients):
- Durable Responses: GI-ORR of 51% at Day 28 and 44% at Day 56. ORR for all organs was 49% at Day 28 and 42% at Day 56.
- Overall Survival (OS): 53% at 6 months, 47% at 12 months, and 42% at 24 months.
- Median Follow-up: 418 days (range: 27-1644 days).
Subset of 58 patients (similar to Phase 3 ARES trial population):
- Higher Response Rates: GI-ORR of 59% at Day 28 and 54% at Day 56. ORR for all organs was 55% at Day 28 and 56% at Day 56.
- OS: 54% at 6 months, 49% at 12 months, and 40% at 24 months, compared to 15% at 12 months in historical data (Abedin et al. Br J Haematol. 2021 Nov).
Upcoming Events & Milestones:
- Webcast on December 17th, 2024: MaaT Pharma will host a webcast at 6:00 PM CET/12:00 PM ET/9:00 AM PT to discuss the latest EAP data and future milestones. [Register here].
- Topline Phase 3 ARES Trial Results: Expected in January 2025, which should further confirm MaaT013’s ability to address the unmet medical needs of aGvHD patients with limited therapeutic options.
About MaaT Pharma: MaaT Pharma, founded in 2014 and listed on Euronext Paris (MAAT), is a pioneer in microbiome-driven therapies to modulate the immune system, aiming to improve cancer patient survival. The company uses proprietary pooling and co-cultivation technologies to develop diverse, standardized microbiome therapies.
About MaaT013: MaaT013 is a standardized, pooled-donor enema-based Microbiome Ecosystem Therapy™ for acute GvHD. It restores the balance of the gut microbiome to enhance immune response and reduce gastrointestinal (GI)-predominant aGvHD, especially in steroid-resistant cases. MaaT013 has Orphan Drug Designation from both the FDA and EMA.
About Acute Graft-versus-Host Disease (aGvHD): aGvHD is a serious complication of stem cell or bone marrow transplants, where donor cells attack the recipient’s body. GI-aGvHD causes severe, life-threatening diarrhea, and patients who do not respond to steroids are considered steroid-resistant (SR). Currently, ruxolitinib is the only approved treatment for SR-aGvHD after steroid failure.
