MaaT Pharma Receives U.S. FDA Response Outlining Path Forward for Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease and Reports Cash and Revenues for Fourth Quarter 2022
03 Februar 2023 - 07:30AM
Business Wire
Regulatory News:
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 reported that the U.S. Food and Drug
Administration (FDA or the “Agency”) has responded to the
Company’s Investigational New Drug (IND) Application to initiate in
the U.S. an open-label, single arm Phase 3 pivotal clinical trial
evaluating the safety and efficacy of MaaT013 in patients with
steroid-resistant acute Graft-versus-Host Disease (aGvHD). The FDA
letter indicates that the Agency agrees to a defined list of
conditions that could enable clinical evaluation of MaaT013 in the
U.S. These measures will be included, by the Company, in the IND
filing. The communication therefore provides a path forward
regarding MaaT Pharma’s “pooling” technology for this IND. The
Company will promptly prepare a complete response letter and in the
interim, the clinical hold remains.
“We appreciate the FDA’s continued commitment and are satisfied
that the Agency has provided a clear and, we believe, achievable
roadmap for the MaaT013 IND,” said Hervé Affagard, CEO and
co-founder of MaaT Pharma. “The dialogue with the FDA remains
constructive and positive as it lays the groundwork for the
clinical evaluation of our pipeline in the U.S. We are confident
about implementing the next steps and we will update investors in
due course.”
As announced in August 2022, the FDA had requested further
clinical and manufacturing-related information including data on
the safety and efficacy of the Company’s “pooling” technology
approach (i.e., mixing donations from multiple donors to achieve
higher richness, diversity, and better standardization of the
product). The Company submitted to the FDA detailed responses to
these requests as announced in the press release dated January 24,
2023. In parallel, and as a reminder, the Company continues the
development of MaaT013 in Europe with its ongoing international
multicenter open-label, single arm, pivotal Phase 3 trial “ARES”
evaluating MaaT013, which is progressing as planned. A review by an
independent data safety and monitoring board (DSMB), is expected in
the first half of 2023 after enrollment of half of the patients in
the study.
Separately from the information above, MaaT Pharma reported
its cash position as of December 31, 2022, and its revenues for the
fourth quarter of 2022.
Cash position1
As of December 31, 2022, total cash and cash equivalents were
EUR 35.2 million, as compared to EUR 40.3 million as of September
30, 2022 and EUR 43.3 million as of December 31, 2021. The net
decrease in cash over the fourth quarter 2022 was EUR 5.1 million
reflecting financing of operations and the ongoing development
programs fully in line with the plans. As announced in a press
release on January 24, 2023, the Company has extended its cash
runway to end of Q4 2023, as compared to end of Q3 2023 as
previously announced.
Revenues in Q4 20231
MaaT Pharma reported gross revenues of EUR 0.6 million for the
quarter ended December 31, 2022, compared with EUR 0.4 million for
the same period of 2021. Full year gross revenues for 2022 amount
to EUR 1.4 million compared to EUR 1.0 million in 2021. Revenues
correspond to compensation invoiced in relation to the
compassionate access program, as approved by the French National
Drug Safety Agency (Agence Nationale de Sécurité du Médicament or
ANSM).
About MaaT013
MaaT013 is a standardized, high-richness, high-diversity
Microbiome Ecosystem TherapyTM containing ButycoreTM (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®, 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 Unaudited data
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version on businesswire.com: https://www.businesswire.com/news/home/20230202005933/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 Gretchen SCHWEITZER or Jacob VERGHESE +49 151
7441 6179 maat@trophic.eu
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