- Positive efficacy and good safety results from 111
patients with acute graft-versus-host disease (aGvHD) treated with
MaaT013 in Early Access Program presented at 2023 ASH Meeting
- Gastrointestinal overall response rate (GI-ORR) of 53% observed
at day 28 positively and significantly impacted overall survival
(OS) in responder patients
- OS results were even more pronounced (81% for responders and 8%
for non-responders) in population matching patients in the Phase 3
ARES clinical trial (GI-ORR of 61% at day 28)
- Design of ongoing Phase 2b Trial in Europe evaluating MaaT033
in patients receiving allogeneic hematopoietic stem cell
transplantation presented at 2023 ASH Meeting
Company to host key opinion leaders’
discussion on Monday, December 18 at 6:00 pm CET. To register,
please click here.
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 of
patients with cancer, presented positive results from the Early
Access Program (EAP) in Europe involving 111 patients with
steroid-refractory (SR) or steroid-dependent (SD) gastrointestinal
acute graft-versus-host Disease (GI-aGvHD) treated with MaaT013, at
the 2023 American Society of Hematology (ASH) Annual Meeting.
“GvHD remains a significant challenge and source of mortality
following allogeneic HSCT,” said Professor Mohty, Professor of
Hematology at Sorbonne University, and head of the Clinical
Hematology and Cellular Therapy Department at Saint-Antoine
Hospital, Paris, France. “The clear connection between
treatment response and overall survival demonstrates Microbiome
Therapies as a potentially life-saving approach, particularly in
patients who have failed earlier treatment lines, corticosteroids
and ruxolitinib. MaaT013 introduces a novel therapeutic approach by
restoring the gut microbiome ecosystem, offering a distinct
immuno-restorative option that could complement standard
immunosuppressive drugs, and could become a potential breakthrough
for patients with limited options.”
“These promising findings pave the way for advancing the
treatment landscape for aGvHD, with microbiome-based innovations,
especially when they achieve complete responses,” said Hervé
Affagard, CEO and co-founder of MaaT Pharma. “It reinforces our
approach based on restoring patients’ immune systems through gut
microbiome ecosystem therapies. The efficacy and safety results
underscore the strong favourable benefit-risk profile for MaaT013,
and we look forward to continuing to investigate MaaT013 with the
aim of having it accessible globally for patients in need as soon
as possible.”
MaaT013 shown to have a safe profile and translates into
increased overall survival:
- GI-ORR of 53% at day 28, with Complete Response observed in
more than two thirds of responders (35%); Overall Response Rate
(ORR) considering all organs was 50% with 31% Complete Response
(CR).
- OS was 56% at 6 months and 47% at 12 months with a median
follow up of 355 days.
- OS was significantly higher in patients who responded to
MaaT013 compared to non-responders (67% versus 24% at 12
months).
The Company defined a subgroup of 38 patients with similar
treatment sequence to the ongoing Phase 3 ARES clinical trial,
which included patients previously treated with steroids and
ruxolitinib. GI-ORR was 61% at day 28, mainly driven by GI Complete
Response (CR) with 58%. ORR was 54% including 51% with CR. Overall
Survival (OS) in this group was 55% at 6 months and 52% at 12
months, confirming the CR as a proxy of survival at one year. OS
was significantly higher in responders to MaaT013 treatment
compared to non-responders (81% versus 8% at 12 months,
respectively).
MaaT013, a pooled-donor microbiome ecosystem therapy, displayed
a good overall tolerability and safety profile in the EAP
population. As of today, MaaT013 has been administered to more than
200 patients. Full details on safety are available here. A Phase 3
trial is currently ongoing in Europe to confirm these results in
ruxolitinib-refractory patients (NCT04769895) with ORR expected in
mid-2024. The Company has an open-IND granted by the U.S. FDA with
active discussions ongoing with potential clinical investigation
sites.
MaaT Pharma also presented its ongoing Phase 2b trial design for
MaaT033, its second candidate, at the 2023 ASH Annual Meeting.
Developed as an adjunctive therapy to enhance OS in HSCT
(hematopoietic stem cell transplantation) and cellular therapy
recipients, MaaT033 targets optimal microbiota function for a
broader patient population in a chronic setting. This
international, multi-centre trial (NCT05762211) is the largest
randomized controlled study to date of a microbiome-based therapy
in oncology, spanning up to 56 sites and enrolling 387
patients.
Company to host key opinion leaders’
discussion on Monday, December 18 at 6:00 pm CET. To register,
please click here.
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 launched, in
March 2022, an open-label, single arm, phase 3 clinical trial in
patients with acute GvHD (aGvHD), 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).
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized,
pooled-donor, enema Microbiome Ecosystem TherapyTM for acute,
hospital use. 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 and thus reduce steroid-resistant, gastrointestinal
(GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug
Designation by the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA).
About acute graft-vs-host-disease
aGvHD occurs in patients within 100 days of undergoing a stem
cell or bone marrow transplant. The transplanted cells “attack” the
recipient, causing inflammation of the skin, liver and/or GI tract.
GI-aGvHD results in patients experiencing extensive diarrhea which
can be life-threatening. The standard first line therapy for
treating aGvHD is the use of systemic steroids. If patients do not
respond to steroids, they are considered steroid resistant (SR) and
other agents can be administered. Currently, the only agent
approved for treating SR aGvHD after failure of steroid treatment
is ruxolitinib, which is currently approved for this indication in
the USA and has received approval from the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP) on
March 25, 2022.
About the Early Access Program
The Early Access Program (EAP) is coordinated and implemented by
European Member States, which set their own rules and procedures to
grant patients early access to certain medications or treatments,
especially when facing life-threatening conditions and lacking
alternative options. It allows for the use of these interventions
before formal approval, acknowledging the urgent medical needs of
individuals who might benefit from them. Healthcare professionals
make the formal request to access this treatment. MaaT013 has been
used in the EAP since 2019. It encompassed a diverse cohort of
patients diagnosed with SR/steroid-dependent (SD) GI-aGvHD, with
various aGvHD classifications – mainly grade III (49%) and grade IV
(42%).
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231210255631/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 Jacob VERGHESE or Priscillia
PERRIN +49 151 7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
過去 株価チャート
から 3 2024 まで 4 2024
Maat Pharma (EU:MAAT)
過去 株価チャート
から 4 2023 まで 4 2024
