MaaT Pharma Announces Update on U.S. FDA Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease
10 August 2022 - 06:00PM
Business Wire
MaaT Pharma (EURONEXT:
MAAT – the “Company”), a French clinical-stage biotech and a
pioneer in the development of Microbiome Ecosystem TherapiesTM
(MET) dedicated to improving survival outcomes for patients with
cancer, today announced that it received a communication from
the U.S. Food and Drug Administration (“FDA” or “the Agency”)
related to the Company’s Investigational New Drug (IND) application
filed in June 2021 to initiate in the U.S. an open-label,
single-arm Phase 3 clinical trial of the Company’s drug candidate,
MaaT013, in patients with steroid-resistant acute Graft-versus-Host
Disease (aGvHD). Following questions raised by the FDA in August
2021 on this application in a clinical hold letter, the Company had
previously submitted a request for a Type A meeting, as well as
detailed responses to the Agency’s questions.
A response letter was received in the evening on August 8th,
2022, Central European Time (CET). It indicates that the Agency
maintains the clinical hold on MaaT013 in the U.S. and details the
FDA’s position on the clinical trial. The Agency acknowledged that
it received satisfactory answers from the Company on multiple
clinical and manufacturing-related questions that the Agency had
initially raised. However, the Agency requires additional
information, notably regarding the safety and efficacy of the
Company’s “pooling” approach (i.e. mixing donations from multiple
donors to achieve higher richness, diversity and better
standardization of the product). The Company is also evaluating
additional recommendations made by the Agency regarding the trial
design.
“We value the FDA’s continued engagement as we seek to extend
the Phase 3 clinical trial of MaaT013 to the U.S. and we intend to
work with the Agency to resolve the issues raised in the
communication, while implementing a defined strategic plan to
continue to deliver on our key milestones,” said Hervé Affagard,
CEO and co-founder of MaaT Pharma. “To date, data gathered from
more than 120 patients with aGvHD who received MaaT013 in Europe as
part of our early access program in France and our completed Phase
2 trial in Europe, indicated a positive safety and efficacy profile
for MaaT013. We remain focused on bringing innovative and safe
microbiome therapies to patients with refractory aGvHD.”
MaaT Pharma is now in the process of preparing the next steps in
the interaction with the FDA, potentially including a Type A
meeting dedicated to discussing the remaining questions. In
parallel and in line with its goal to reach patients globally, the
Company will continue the development of MaaT013 in Europe and
expand European recruitment for its ongoing Phase 3 trial
evaluating MaaT013 in 75 patients. There are currently 19 active
clinical sites in France, Germany, and Spain and the Company has
submitted clinical trial applications in three additional European
countries. The overall expected timelines for the Phase 3 trial
and, if approved, commercialization of MaaT013 in Europe remain
unchanged.
In parallel, the Company continues to prepare for the initiation
of a Phase 2/3 trial in Europe to evaluate its second native
(donor-derived) asset, MaaT033, in patients with blood cancers
receiving allogeneic hematopoietic stem cell transplantation
(allo-HSCT). This clinical study is expected to start in Q4
2022.
The Company also continues to prepare a first-in-human trial of
its first co-fermented MaaT03X candidate in both Europe and the
U.S. This new class of drug candidates aims to improve the
anti-cancer efficacy of immune checkpoint inhibitors in patients
with a yet undisclosed solid tumor having a high unmet need.
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 in Europe, a Phase 3 clinical trial for patients with
acute GvHD, following the achievement of its proof of concept in a
Phase 2 trial. 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 the first company developing microbiome-based
therapies 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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version on businesswire.com: https://www.businesswire.com/news/home/20220810005587/en/
MaaT Pharma – Investor Relations 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 and Medical
Communications Jacob VERGHESE or Gretchen SCHWEITZER +49 89
2070 89831 maat@trophic.eu
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