- Data from 76 patients with acute Graft-vs-Host Disease (aGvHD) treated with MaaT013 will be presented.
- Oral presentation will highlight MaaT013’s potential in improving survival outcome for patients with gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD).
- The data, previously shared at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021, include results from HERACLES Phase 2 trial in 24 patients with steroid-resistant Grade III-IV GI-aGvHD and from the Early Access Program in France in 52 patients with Grade II-IV GI-aGvHD having failed previous therapies.
LYON, France–(BUSINESS WIRE)–$MAAT–Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, announced today that positive results from its Phase 2 trial HERACLES (NCT03359980, n=24) and from its compassionate use program (EAP, n=52) for lead microbiome therapy MaaT013 will be reported in an oral presentation at the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2022) held as an online event from March 19th to March 23rd, 2022.
The data, previously presented at the American Society of Hematology in December 2021, showed that MaaT013 treatment in patients that developed GI-aGvHD following hematopoietic cell transplantation demonstrated promising objective gastro-intestinal response rates (GI-ORR) in both groups. The observed GI-ORR with MaaT013 treatment at day 28 was 38% in the HERACLES trial, including 5 complete responses (21%), and 58% in the EAP patients, including 17 complete responses (33%). The 12-month overall survival in patients who responded to treatment was 44% in HERACLES and 59% in the EAP program.
Results will be live-streamed and presented by Dr. Florent Malard, Associate Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University, who participated in the HERACLES clinical trial.
Oral Presentation details (virtual live session):
Title: Pooled Allogenic Fecal Microbiotherapy MaaT013 for the Treatment of Steroid-Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Phase 2a Heracles Study and Expanded Access Program
Abstract number: OS10-06
Session Name: OS10 Oral session 10: GVHD I, clinical
Date/Time: Wednesday, March 23, 9:45 am – 9:54 am CET
Link to register: https://urlz.fr/hHX6
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, Microbiome Ecosystem Therapy. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). 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. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its development in treating acute Graft-versus-Host Disease (aGvHD).
About MaaT Pharma
MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. 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 a Phase 2 clinical trial in acute GvHD. Its powerful discovery and analysis platform, gutPrint®, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions.
The company’s 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 support the integration of the use of microbiome therapies in clinical practice.
MaaT Pharma is listed on Euronext Paris (ticker: MAAT).
Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof.
Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
Contacts
MaaT Pharma – Investor relations
Hervé AFFAGARD
Co-Founder and CEO
Siân Crouzet, COO/ CFO
+33 4 28 29 14 00
invest@maat-pharma.com
MaaT Pharma -media relations
Pauline RICHAUD
Senior PR & Corporate
Communications Manager
+33 6 07 55 25 36
prichaud@maat-pharma.com
Trophic Communications –
Corporate and medical Communications
Jacob VERGHESE or
Gretchen SCHWEITZER
+49 89 23 88 77 31
maat@trophic.eu