MaaT Pharma Announces Publication of Results in eClinicalMedicine Journal Highlighting Clinical Benefit of MaaT013 in aGvHD
26 Julho 2023 - 1:00PM
Business Wire
- Data on 76 patients with gastrointestinal acute
Graft-versus-Host Disease treated with MaaT013 published in
eClinicalMedicine, one of The Lancet Discovery Science suite’s
journals
- Ongoing Phase 3 trial built on positive data from Phase 2
HERACLES study and ongoing early access program (EAP) in France:
both datasets showed that MaaT013 was well-tolerated in
immunocompromised patients and had promising clinical benefits
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
improving survival outcomes for patients with cancer, today
announced that eClinicalMedicine has published clinical data on
MaaT013 as a treatment for acute Graft-versus-Host Disease (aGvHD).
The data includes results from 24 patients in a Phase 2 clinical
trial and 52 patients enrolled in the Early Access Program (EAP) in
France. The article entitled “Pooled allogeneic faecal microbiota
MaaT013 for steroid-refractory gastrointestinal acute
graft-versus-host disease: a single-arm, multicentre phase 2 trial”
can be accessed here.
"Data show encouraging clinical outcomes and survival rates for
very severe patients with acute GvHD, thereby opening new treatment
avenues," said Pr. Florent Malard, Professor of Hematology at
the Saint-Antoine Hospital and Sorbonne University. "Based on
this promising clinical data, including the good tolerability and
safety profile, we eagerly anticipate the results of the ongoing
evaluation of MaaT013 in Phase 3."
"The publication of our results in a peer-reviewed journal
underlines the importance of the microbiome in the
hematology-oncology field. Indeed, the data suggests that the
successful re-establishment of a functional microbiome through our
innovative MET MaaT013 is associated with patient response,”
commented Hervé Affagard, CEO and co-founder of MaaT
Pharma.
The Phase 2a HERACLES trial evaluated MaaT013's safety and
efficacy in patients with grade III-IV steroid-refractory
gastrointestinal aGvHD after allogeneic hematopoietic stem cell
transplantation. The gastrointestinal Overall Response Rate was 38%
in the trial population and 58% in the EAP population.
Interestingly, patients responding at day 28 exhibited a higher
microbiota richness and greater proportions of MaaT013-derived
beneficial species from multiple donors, that could suggest a
clinical impact from pooling donors. MaaT013's safety profile was
consistent with previous findings. Clinical data in the article
were also previously presented at the 2021 American Society of
Hematology Annual Meeting. For HERACLES, Overall Survival (OS) in
responding patients at the 12-month follow-up was 44%, compared to
13% in non-responders (OS in all included patients was 25% at 12
months). For EAP, the 12-month OS in responding patients was 59%,
compared to 7% in non-responders (OS in all included patients was
38% at 12 months). As a reminder, OS in ruxolitinib-resistant
patients at 2 months is 22% (REACH1 study). The drug candidate
MaaT013 is currently being evaluated in the pivotal ARES study, the
first global phase 3 trial in hemato-oncology.
About HERACLES
The HERACLES trial (NCT03359980), a multi-center, single-arm,
open-label study, analyzed the efficacy and safety of MaaT013 in
patients with grade III-IV GI-predominant aGvHD after
allogeneic-HSCT whose standard failed first-line treatment of
high-dose corticosteroids. A total of 24 patients, including 21 in
the per-protocol analysis, received at least one, and up to three
doses, of MaaT013, and treatment response was evaluated seven days
after each administration and on day 28 after the first dose.
Patient follow-up was performed at 3 months and 6 months, with a
final follow-up at 12 months after study inclusion.
About MaaT013
MaaT013 is a standardized, high-richness, high-diversity
Microbiome Ecosystem TherapyTM containing ButycoreTM (i.e., a group
of bacterial genera known to produce immuno-regulatory
metabolites). It 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
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).
MaaT013 is an off-the-shelf, healthy-multi-donors-derived product
intended for acute, hospital use.
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 Charlotte SPITZ
or Stephanie MAY +49 171 351 2733 maat@trophic.eu
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