MaaT Pharma Presents Promising Detailed Results from Completed Phase 1b Trial with MaaT033 at the 64th ASH Annual Meeting
2022年12月12日 - 12:00AM
ビジネスワイヤ（英語）
- Detailed results from completed Phase 1b CIMON trial in 21
acute myeloid leukemia (AML) patients treated with the company’s
Microbiome Ecosystem TherapyTM (MET) oral capsule, MaaT033,
demonstrating its safety and ability to increase gut microbiota
richness.
- Results of the study evaluating the tolerated dose of MaaT033
in patients with AML showed initial engraftment of beneficial
bacterial species.
- Company presented topline results in June 2022 and confirms its
intention to conduct a Phase IIb pivotal trial shortly in order to
evaluate MaaT033 to prevent complication of allo-HSCT. Readiness
activities have continued in Q4.22 destined to optimize the
protocol in light of deeper data analysis.
Company to host investor webcast on Monday,
December 12 at 6:00 pm CET/12:00pm EST. To register and
access the webcast, please click here. A replay will be made
available shortly after the conclusion of the webcast and archived
on MaaT Pharma’s website for at least 90 days.
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French
clinical-stage biotech and a pioneer in the development of
Microbiome Ecosystem TherapiesTM (MET) dedicated to improving
survival outcomes for patients with cancer, today presented
detailed results from the completed Phase 1b CIMON trial with
MaaT033 at the Annual Society of Hematology (ASH) Annual Meeting in
New Orleans, U.S. To access the abstract, please click here.
“MaaT Pharma’s mission is to improve cancer patients’ lives by
driving innovation in the microbiome therapeutics field,” said
Hervé Affagard, CEO and co-founder of MaaT Pharma. “These
positive Phase 1b results reinforces the strong potential for our
MET oral formulation, MaaT033, and we plan to investigate it as an
adjunctive and maintenance treatment in patients with hematological
malignancies.”
Prof. Mohamad Mohty added, “Allo-HSCT is often the only
curative approach for patients with hematological malignancies such
as acute leukemia. Evidence of a significant reduction in the risk
of infection and GvHD-related mortality following stem cell
transplantation has been associated with a higher gut microbiome
diversity. Our ability to maintain or induce a high richness, and a
high diversity gut microbiome would be key to prevent or minimize
these adverse effects and contribute to a better overall prognosis
for these patients.”
Key clinical findings with MaaT033 in Phase 1b study
CIMON
In the dose-finding Phase 1b CIMON trial, 21 patients with acute
myeloid leukemia (AML) were treated with MaaT033 and evaluated for
safety, tolerability, and initial signs of microbial species
engraftment.
- MaaT033 was shown to be safe and tolerable in 21 patients. 4
severe adverse events (SAEs) were reported in 4 patients, only one
considered as possibly related by the investigator.
- Treatment with MaaT033 induced increased microbiota richness as
well as strong and persistent engraftment in cohorts 3 and 4 of the
dose escalation study, which consisted in the intake of 3 capsules
of the drug candidate per day.
- Engraftment following MaaT033 treatment correlated with
increased anti-inflammatory marker levels and reduced inflammatory
marker levels.
Detailed results from the Phase 1b CIMON trial were presented in
a poster on December 11 at the ASH Annual Meeting by Prof.
Mohamad Mohty, Head of the Clinical Hematology and Cellular
Department at the Saint-Antoine Hospital and Sorbonne
University.
As previously announced, MaaT Pharma is currently preparing a
pivotal Phase IIb randomized, double-blind, placebo-controlled to
evaluate MaaT033’s safety, engraftment, and efficacy in improving
overall survival at 12 months and preventing complications in
patients with blood cancers receiving hematopoietic stem cell
transplantation. Initiation should take place shortly and the
Company will provide a detailed status update in January 2023.
About MaaT033
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized,
pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033
is designed to restore the gut ecosystem to full functionality to
improve clinical outcomes as well as to control adverse events
related to conventional treatments for liquid tumors. The capsule
formulation facilitates administration while maintaining the high
and consistent richness and diversity of microbial species,
including anti-inflammatory ButycoreTM species.
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 launched, in
March 2022, a Phase 3 clinical trial for patients with acute GvHD,
following the achievement of its proof of concept in a Phase 2
trial. 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 the first company developing microbiome-based
therapies 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221211005029/en/
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
media@maat-pharma.com
Trophic Communications - Corporate and medical
Communications Jacob VERGHESE or Gretchen SCHWEITZER +49 151
7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
過去 株価チャート
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Maat Pharma (EU:MAAT)
過去 株価チャート
から 10 2023 まで 10 2024
