- Data from 29 patients in the company’s early access program with MaaT013 as a treatment for gastrointestinal acute Graft-versus-Host Disease will be highlighted in an oral presentation
- Topline data from the Phase 2 HERACLES clinical trial with MaaT013 will be announced near-term
Lyon, France, March 11, 2021 – MaaT Pharma announced today that data from its early access program for lead microbiome ecosystem therapeutic, MaaT013, will be reported in an oral presentation at the virtual 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) taking place from March 14 – March 17, 2021. The data was previously presented at the American Society of Hematology in December 2020. MaaT013 is an enema formulation of a full ecosystem microbiota biotherapeutic characterized by a consistent high diversity and richness of microbial species derived from pooled healthy donors The results include data from 29 patients with gastrointestinal, acute Graft-versus-Host-Disease (aGvHD) who were resistant to up to 5 lines of treatments and were then treated with MaaT013 as part of an early access program in France. Positive GI aGvHD response at Day 28 was achieved in 59% (17/29) of patients.
As the conference is held virtually this year, the oral presentation by Dr. Florent Malard, Associate Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University who participated in the treatment program, will be recorded and available throughout the duration of the conference in the On-Demand Library section.
Oral presentation details:
Title: Successful And Safe Treatment Of Intestinal GvHD with Pooled-Donor Full Ecosystem Microbiota Biotherapeutic: Results from a 29 Patient-Cohort of a Compassionate Use/Expanded Access Treatment ProgramSession Name: OS8-6Location: On-Demand LibraryDate/Time: March 14 – March 17, 2021 / accessible anytime
In addition to the early access program, MaaT Pharma investigated its lead candidate, MaaT013, in a multi-center, single-arm, open-label, Phase 2 clinical trial, called HERACLES to evaluate the safety and efficacy of MaaT013 in gastrointestinal-predominant, steroid-refractory, acute GvHD (GI SR-aGvHD) patients (NCT03359980). Topline data from the completed HERACLES clinical trial will be announced shortly.
MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic in enema formulation. The product is characterized by a high diversity and consistent richness of microbial species. MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is being investigated in a Phase 2 clinical trial (NCT03359980) and is already being administered in an early access program.
About MaaT Pharma
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients and a Phase 2 clinical trial in acute GvHD is completed. Supporting the development and expansion of our pipeline, we have built a powerful discovery and analysis platform, GutPrint®, to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.