On November 6, 2019 MaaT Pharma reported that a poster will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting with initial data on it’s lead microbiome restoration biotherapeutic, MaaT013, as a treatment in patients with gastrointestinal-predominant, Steroid-Refractory and Steroid-Dependent acute Graft-versus-Host-Disease (GI aGvHD) following allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT) (Press release, MaaT Pharma, NOV 6, 2019, View Source [SID1234550531]). MaaT Pharma provided the product as a pharmaceutical preparation to hospitals as part of its compassionate use program for patients who had previously received and failed up to five previous systemic treatments for GvHD. MaaT013 is an enema formulation of a microbiota biotherapeutic characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors. The product is manufactured at the company’s centralized European cGMP production facility using its proprietary microbiome restoration biotherapeutic platform. The poster will be presented during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida from December 7 – 10, 2019. The poster abstract was published in the online meeting program on November 6, 2019 at 9:00 AM EDT and also in the online November supplemental issue of the journal Blood.
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Poster Presentation details:
Title: Successful and Safe Treatment of Intestinal Graft-Versus-Host Disease (GvHD) with Pooled-Donor Full Ecosystem Microbiota Biotherapeutics
Abstract No: 1993
Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GvHD, Immune Reconstitution: Poster I
Date/Time: Saturday, December 7, 2019 / 5:30 PM – 7:30 PM EDT
Location: Orange County Convention Center, Hall B
MaaT Pharma will announce the results through a press release following the presentation and will further make the poster available on the company website under "News".
In addition to the compassionate use program, MaaT Pharma is currently investigating MaaT013 in a Phase II clinical trial in acute SR GI GvHD patients (NCT03359980). The study, named HERACLES, is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the safety and efficacy of MaaT013 in steroid-resistant, gastrointestinal-predominant aGvHD (SR GI aGvHD) patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin and liver. MaaT Pharma has established the most complete approach to restoring patient-microbiome symbiosis in the gut to improve efficacy of cancer treatments and survival outcomes in life-threatening diseases. The company announced in June this year the completion of a third positive safety assessment of MaaT013 in the Phase II trial by an independent Data and Safety Monitoring Board (DSMB). MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).