MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event
15 April 2024 - 7:30AM
Business Wire
- Positive efficacy and safety results in 140 patients treated
with MaaT013 in acute graft-versus-host disease (aGvHD) as part of
the MaaT Pharma Early Access Program (EAP).
- Gastrointestinal overall response rate (GI-ORR) of 52% observed
at Day (D) 28.
- Long-term survival data at 18 months with 42% overall survival
(OS) in all patients and 58% in responder patients to MaaT013.
- Used in 3rd line, MaaT013 exhibits a high and durable response
rate (with 63% GI-ORR at D28 and 53% at D56), translating to the
highest overall survival in this population of patients when
compared to reported evidence in the literature (Abedin et al.,
2021).
- A pivotal Phase 3 trial evaluating MaaT013 (ARES trial -
NCT04769895; n=75) in patients with corticosteroid and
ruxolitinib-refractory GI-aGvHD is currently ongoing with primary
endpoint expected in mid Q4-2024.
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage
biotechnology company and a leader in the development of Microbiome
Ecosystem Therapies™ (MET) dedicated to enhancing survival for
patients with cancer, presents a summary of its oral presentation
at the 50th Annual Meeting of the European Society for Blood and
Marrow Transplantation (EBMT) currently being hosted in Glasgow,
Scotland from 14-17 April 2024. The presentation is scheduled for
April 17th by Dr. Malard, Professor of Hematology at Saint-Antoine
Hospital and Sorbonne University in Paris and is based on the
abstract made available on the website of the event.
This presentation will unveil promising extended outcomes from
the EAP in Europe, involving 140 patients with steroid-refractory
(SR) or steroid-dependent (SD) gastrointestinal acute
graft-versus-host disease (GI-aGvHD) treated with MaaT013. Prof.
Malard will emphasize a significantly high response rate (Complete
Response [CR] and Very Good Partial Response [VGPR]) to MaaT013,
demonstrating a clear reduction in disease burden and improved
Overall Survival (OS) at 18 months compared to published data.
Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18
months, yielding more complete responses in aGvHD patients who have
shown resistance to current treatments, as compared to other
available therapies. This effect is coupled with reduced toxicity
compared to standard immunosuppressive drugs. Notably, these
results are achieved with just 3 doses in less than 2 weeks of
treatment initiation. This would not only improve patient outcomes,
but also significantly enhance their quality of life.”
Echoing this feedback, Dr. Jaime Sanz Caballer, Hematologist and
coordinator of the Bone Marrow Transplant Unit at the University
Hospital La Fe in Valencia, Spain, also commented: “there is a
persistent unmet medical need in aGvHD with consistently reported
poor survival outcomes. This is particularly noticeable for
patients in third-line treatment options where only 15% of patients
survive at 12 months1. This underscores the urgent demand for
innovative solutions such as MaaT013, presenting a promising
immuno-restorative approach."
The data presented highlights the strong safety profile of
MaaT013 (full details here) and translates into increased OS. In
this heavily pre-treated population (n=140), the following results
were observed:
- GI-ORR of 52% at D28, with CR observed in 28% of patients; ORR
considering all organs was 52% with 24% CR.
- OS was 54% at 6 months, 47% at 12 months, 42% at 18
months.
- OS was significantly higher in patients who responded to
MaaT013 compared to non-responders (68% versus 24% at 12 months,
and 58% versus 24% at 18 months).
A subset of the 140 patients (n=49) that is a similar population
to that of the ongoing Phase 3 ARES clinical trial (NCT04769895):
steroid- and ruxolitinib- refractory corresponding to the
third-line treatment demonstrated even better efficacy:
- GI-ORR of 63% at D28, with almost half of patients
demonstrating a CR (49%); global ORR was 61% with 43% with a
CR.
- OS was 52% at 6 months, 49% at 12 months, 42% at 18
months.
- OS was significantly higher in patients who responded to
MaaT013 compared to non-responders (76% versus 6% at 12 months, and
64% versus 6% at 18 months).
A pivotal Phase 3 trial (n=75) evaluating MaaT013 (ARES trial -
NCT04769895) in patients with corticosteroid and
ruxolitinib-refractory GI-aGvHD is currently ongoing to confirm the
results from the EAP. The Company previously shared the positive
review by the Data Safety Monitoring Board (DSMB) for the Phase 3
ARES trial, including a favorable benefit/risk ratio, with “high
efficacy and low toxicity.”
“The confirmation of an improvement in 18-month survival,
compared to the data already presented, by the company, at 12
months, reinforces our confidence in the ongoing development,
notably the results of the current Phase 3 trial,” stated Hervé
Affagard, CEO and co-founder of MaaT Pharma. “Beyond the
significant impact for patients, this advancement distinguishes our
treatment in a context where current options offer only limited
benefits and lead to severe complications. Anticipating a positive
Phase 3 outcome and a potential commercial launch in 2026, we aim
to capture a substantial share of the market for third-line
patients, thereby marking a turning point in the management of this
condition.”
MaaT013, a pooled-donor microbiome ecosystem therapy, has been
awarded Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) due to the
rarity of the disease, underscoring the need for therapeutic
advances.
MaaT Pharma also presented its ongoing Phase 2b trial design for
MaaT033 developed as an adjunctive therapy to enhance OS in
allogeneic hematopoietic stem cell transplantation. This
international, multi-center trial (NCT05762211) is the largest
randomized controlled study to date of a microbiome-based therapy
in oncology, spanning up to 56 sites and aiming to enroll 387
patients.
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 study. 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 Abedin et al, 2021
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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 – Corporate Communications Jacob
VERGHESE or Priscillia PERRIN +49 151 7441 6179 maat@trophic.eu
Maat Pharma (EU:MAAT)
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