MaaT Pharma Announces First Patient Dosed in Phase 2b Randomized Clinical Trial Evaluating MaaT033 in Patients Receiving Allo-HSCT
06 11월 2023 - 3:30PM
Business Wire
- PHOEBUS is a Phase 2b randomized placebo-controlled trial
investigating MaaT033 as an adjunctive therapy to improve 12-month
overall survival rates for allogeneic hematopoietic stem cell
transplant (allo-HSCT) patients
- MaaT033, the Company’s second drug candidate, is a
donor-derived full microbiome ecosystem capsule applicable for
ambulatory care
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, announced today
that the first patient has been treated as part of its Phase 2b
trial, called PHOEBUS, investigating the efficacy of MaaT033 in
improving overall survival (OS) at 12 months for patients with
blood cancer receiving allo-HSCT. The trial is an international,
multi-center, randomized, double-blind, placebo-control study
(NCT05762211), which will be conducted in up to 56 clinical
investigation sites and is expected to enroll 387 patients. It is
to date the largest randomized controlled trial assessing a
microbiome therapy in oncology.
“Today marks a significant milestone for us as our second
product, MaaT033, enters Phase 2b clinical trials in allo-HSCT. The
opportunity to offer patients a capsule that can be taken at home
not only furthers our overall mission to improve patient survival
in multiple situations, but also reinforces our leadership in the
field, as we believe this program is currently the most advanced in
the microbiome/hemato-oncology field,” said Hervé Affagard, CEO
and co-founder of MaaT Pharma.
Prof. Florent Malard, Professor of Hematology at the
Saint-Antoine Hospital and Sorbonne University, and principal
investigator of the study added, “A growing body of evidence
indicates that gut imbalance leads to higher mortality in our
field. By directly targeting to restore the gut microbiome richness
in patients receiving harsh and deleterious treatments, our goal is
to ensure optimal microbiome functions that can potentially lead to
improved hematopoietic and immune recovery as well as overall
survival.”
To date, the Company has received regulatory approvals from
France and Germany, and the clinical trial will be expanded to
sites in additional countries subject to regulatory approval.
Study objectives:
- Primary endpoint: Overall Survival, evaluated in late 2026. -
Secondary endpoints include evaluation of safety and tolerability
before and after allo-HSCT, and evaluation of the engraftment of
beneficial microbial species from MaaT033.
About MaaT033
MaaT033, a donor-derived, high-richness, high-diversity oral
Microbiome Ecosystem TherapyTM containing anti-inflammatory
ButycoreTM species, is currently being developed as an adjunctive
therapy to improve overall survival in patients receiving HSCT and
other cellular therapies. It aims to ensure optimal microbiota
function and to address a larger patient population in a chronic
setting. MaaT033 has been granted Orphan Drug Designation by the
European Medicines Agency (EMA) in August 2023.
About Allogeneic hematopoietic stem cell transplantation
(allo-HSCT)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
for liquid tumors can replace cancerous cells, but the harsh
conditioning treatments damage the gut microbiome, which has been
linked to decreased survival, increased risk of graft-vs-host
disease, and infections due to impaired immune function. Nearly
20,000 allo-HSCT transplantations per year in Europe were reported
in 2021 by the European Society for Blood and Marrow
Transplantation (EBMT) and continue to increase.
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, an open-label, single-arm Phase 3 clinical trial in
patients with acute GvHD, following the achievement of its proof of
concept in a Phase 2 trial. 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.
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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 Jacob VERGHESE or Priscillia
PERRIN +49 151 7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
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