MaaT Pharma Announces Long Term Follow-Up Data for MaaT013 in Early Access Program to be Presented at the Upcoming EBMT Conference
12 Março 2024 - 3:30AM
Business Wire
- Oral presentation will highlight new data in Early Access
Program (EAP) for patients with acute Graft-vs-Host Disease (aGvHD)
treated with MaaT013.
- This is the seventh year that MaaT Pharma's abstracts have been
chosen for presentation at the EBMT Annual Meeting, confirming the
Company’s leadership in the field of hemato-oncology/
microbiome.
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage
biotechnology company and a leader in the development of Microbiome
Ecosystem TherapiesTM (MET) dedicated to enhancing survival for
patients with cancer, will present extended results from its Early
Access Program for patients with aGvHD that were treated with
MaaT013 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 MaaT013 has an impact on overall
survival (OS) when the primary endpoint (gastrointestinal Overall
Response Rate at D28) is achieved (see press release on data
presented at 2023 ASH[1] annual meeting). To date, over 220
patients have been treated with MaaT013 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 MaaT013
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[2] 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 MaaT013, 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 3 trial (n=75) evaluating MaaT013 (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[3] for the Phase 3 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
- Location: Hall 5
About MaaT Pharma
MaaT Pharma, a leading 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 initiated an
open-label, single-arm Phase 3 clinical trial in patients with
acute GvHD, building on the positive results of its Phase 2
proof-of-concept. Its powerful discovery and analysis platform,
gutPrint®, enables the identification of novel disease targets,
evaluation of drug candidates, and identification of 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.
[1] American Society of Hematology [2] No evidence of aGvHD [3]
Data Safety Monitoring Board
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version on businesswire.com: https://www.businesswire.com/news/home/20240311819202/en/
MaaT Pharma – Investor Relations Guilhaume DEBROAS, Ph.D.
Head of Investor Relations +33 6 16 48 92 50 invest@maat-pharma.com
MaaT Pharma – Media Relations Pauline RICHAUD Senior PR
& Corporate Communications Manager +33 6 14 06 45 92
media@maat-pharma.com Trophic Communications – Corporate
Communications Jacob VERGHESE or Priscillia PERRIN +49 151 7441
6179 maat@trophic.eu
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