- Pivotal Phase 3 clinical trial investigates the efficacy of
lead Microbiome Ecosystem Therapy MaaT013 as third-line treatment
in patients with steroid-resistant gastrointestinal acute
Graft-versus-Host Disease (SR GI-aGvHD)
- ARES is the first Phase 3 trial globally for a microbiome-based
therapy in haemato-oncology
Regulatory News:
MaaT Pharma (EURONEXT:
MAAT - the “Company”), a French clinical-stage biotech and a
pioneer in the development of microbiome-based ecosystem therapies
dedicated to improving survival outcomes for patients with
cancer, announced today that the first patient has been dosed
in its pivotal Phase 3 trial investigating MaaT013 in patients with
acute Graft-versus-Host-Disease with gastrointestinal involvement
(GI-aGvHD) who are refractory to both steroids, the standard of
care first-line treatment, and to ruxolitinib1 used as a
second-line treatment. The open-label, single-arm Phase 3 study
(NCT04769895), called ‘ARES’, evaluates the safety and efficacy of
MaaT013, the company’s high-richness, high-diversity lead
Microbiome Ecosystem Therapy (MET) as a third-line, salvage therapy
in GI-aGvHD patients2. aGvHD is a severe complication of an
allogeneic stem cell transplant and every year, approximately
10,000 patients are diagnosed globally.
“Initiating the pivotal Phase 3 trial with our lead candidate
MaaT013 is an important milestone for our company and for the
microbiome therapeutics field worldwide. If ARES is successful, we
believe this study could serve as the basis for MaaT013’s approval
in this severe indication with a very high unmet need,” said
Hervé Affagard, co-founder and CEO of MaaT Pharma.
ARES is a Phase 3 multicenter, international, open-label,
single-arm study assessing the safety and efficacy of MaaT013 in 75
patients with Grade II-IV GI-aGvHD who are refractory to steroids
and are resistant or are intolerant to ruxolitinib. The clinical
trial will be conducted in up to 40 different sites across the
European Union. To date, the company has received regulatory
approvals from France, Germany and Spain, and the clinical trial
may also be expanded to sites in the United States subject to
regulatory approval. Eligible patients in the ARES study will be
administered a total of 3 doses of MaaT013 as an enema formulation
over a period of 10 days. The primary endpoint of the study is the
GI-overall response rate (GI-ORR) to MaaT013 treatment at day 28.
Secondary endpoints include the safety and tolerability of MaaT013
up to 12 months, as well as overall survival after 12 months. A
first data review is expected in Q1 2023 after enrollment of half
the patients in the study.
Prof. Mohamad Mohty, Professor and Head of the
Hematology and Cellular Therapy Department at the Saint-Antoine
Hospital and Sorbonne University and past-president of the European
Society for Blood and Marrow Transplantation (EBMT) added, “The
medical need is extremely high for GI-aGvHD patients who are
refractory to both steroids and ruxolitinib, as they face an 80%
mortality rate within the first few months3. By restoring the gut
microbiome ecosystem, MaaT013 opens a brand-new therapeutic
modality and provides a strongly differentiated, immuno-restorative
approach that may complement standard immunosuppressive drugs and
may provide a breakthrough for patients with no other therapeutic
options.”
The Phase 3 ARES trial builds on previously shared positive
results from the company’s Phase 2 HERACLES study of MaaT013 (n=
24) and from data of 52 patients benefiting from an ongoing early
access program with MaaT013 in France. Both clinical datasets
demonstrated that MaaT013 was generally well tolerated in this
heavily immunocompromised patient population and demonstrated
promising clinical benefit, which translated into a positive impact
on overall survival rates in patients responding to the treatment.
To date, more than 100 patients with aGvHD have been safely treated
with MaaT013.
About steroid resistant, gastro-intestinal acute
Graft-vs-host-Disease (SR, GI aGvHD)
Acute Graft-versus-Host Disease 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 gastro-intestinal tract. GI-aGvHD results in
patients experiencing very high volumes of 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 USA
and has received approval from the European Medical Agency’s
Committee for Human Medicinal Products (CHMP) on March 25,
2022.
About MaaT013
MaaT013 is a full-ecosystem, off-the-shelf, standardized,
pooled-donor, Microbiome Ecosystem Therapy. 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-predominant aGvHD. MaaT013 has
been granted Orphan Drug Designation by the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA).
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 already
achieved proof of concept in a Phase II clinical trial in acute
GvHD. 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 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 Ruxolitinib was approved for second-line treatment of aGvHD in
the US in 2019 and has received a positive CHMP opinion in Europe
on March 25, 2022
(https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-jakavi-treat-acute-and-chronic-graft-versus-host-disease).
In the absence of a standard of care after first line of treatment,
data from centers benefitting from MaaT Pharma’s early access
program to MaaT013 in France show that up to 70-80% of patients
with GI, SR aGVHD have received ruxolitinib before entering said
program. 2 Median previous lines of treatment: 3. Including 77%
having failed both steroids and ruxolitinib. 3 Source : REACH 1
trial
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version on businesswire.com: https://www.businesswire.com/news/home/20220328005581/en/
MaaT Pharma 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
prichaud@maat-pharma.com
Trophic Communications Corporate Communications Jacob VERGHESE
or Gretchen SCHWEITZER +49 89 23 88 77 31 maat@trophic.eu
Maat Pharma (EU:MAAT)
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