MaaT Pharma Announces Positive Review from the DSMB on the Ongoing Phase 1 Clinical Trial Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)
01 March 2024 - 4:00AM
Business Wire
- Independent Data Safety and Monitoring Board (DSMB) recommended
that the trial proceeds as planned without modifications.
- MaaT033 has shown a good safety profile and was generally well
tolerated in the first 8 patients with ALS treated with MaaT033
used in a chronic setting.
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, today announced that the DSMB reviewed safety
data in the first 8 patients with Amyotrophic Lateral Sclerosis
(ALS) treated with MaaT033 in the IASO clinical trial. The DSMB
recommended that the trial continue without modifications.
The DSMB, composed of 4 independent experts, including an ALS
patient association representative, concluded that safety was good.
More precisely, it should be noted that no serious or severe
adverse events were observed, and no infectious events could be
related to MaaT033. The preliminary results reinforce confidence in
the safety of MaaT033, a drug candidate produced by combining the
microbiota from multiple donors using a "pooling" process.
MaaT033 is currently evaluated, in a chronic setting, in a Phase
1b pilot study (NCT05889572) in ALS (also known as Lou Gehrig's
disease in the US and Charcot's disease in French-speaking
countries). The Company has developed the clinical trial with the
French academic experts FILSLAN/ ACT4ALS-MND and in collaboration
with the French patients’ association Tous en Selles contre la SLA.
Data readout is now expected in early H2 2024. MaaT033 is also
being evaluated in the Phase 2b trial PHOEBUS (NCT05762211), the
largest one to date in Europe for a microbiome therapy in oncology,
dedicated to improving survival of patients with blood cancers
receiving allogeneic hematopoietic stem cell transplantation
(HSCT).
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).
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).
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/20240229517711/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 Stephanie MAY or Priscillia PERRIN
+49 171 185 56 82 maat@trophic.eu
Maat Pharma (EU:MAAT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Maat Pharma (EU:MAAT)
Historical Stock Chart
From Jul 2023 to Jul 2024