MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD

—Independent Data Safety Monitoring Board (DSMB) recommends
HERACLES trial to continue without modification—

—Patient recruitment in the study continues with additional
sites opened in Europe—

LYON, France–(BUSINESS WIRE)–MaaT Pharma announced today that the independent Data and Safety
Monitoring Board (DSMB) recommended the continuation, without amendment,
of the ongoing Phase II HERACLES study (NCT03359980).
The HERACLES trial investigates the use of lead biotherapeutic MaaT013
in steroid-resistant, gastrointestinal-predominant, acute
Graft-versus-Host-Disease (SR GI aGvHD) after allogeneic Hematopoietic
Stem-Cell Transplantation (allo-HSCT). The second review assessed the
safety of MaaT013 after 10 patients treated, reinforcing the absence of
safety issues during the trial as confirmed after the first
review. Enrollment of patients in the trial continues as planned
with additional sites recently opened in Germany and Italy. As of today,
a total of 13 patients have been treated in the protocol.

“The high mortality rate of up to 80% after 6 months in
gastrointestinal-predominant aGvHD poses a significant unmet medical
need and we believe that MaaT013 will improve these patients’ outcomes
through a differentiated approach of restoring their immune
homeostasis,” said Hervé Affagard, Co-founder and CEO of MaaT Pharma.
“The relevance of the microbiome in hemato-oncological diseases is
increasingly recognized by the medical community and our mission is to
develop the first, safe microbiome-based product to help patients with
no other options. We look forward to communicating the top-line data of
this trial later this year.”

Seperately, the Company announced the presentation of the detailed
protocol information on the HERACLES study in a poster at the 45^th
Annual Meeting of the European Society for Blood and Marrow
Transplantation in Frankfurt, Germany, held from March 24^th –
27^th, 2019. The full poster can be accessed on the Company
website through the following link: https://bit.ly/2V2tbnl

About HERACLES

The HERACLES study is a multi-center, single-arm, open-label study,
enrolling 32 patients to evaluate the efficacy and safety of MaaT
Pharma’s lead microbiome restoration drug candidate, MaaT013, in
steroid-resistant gut predominant aGvHD patients. Acute GvHD is a
serious, often fatal syndrome typically involving the gut, skin, and
liver. Treatments up to now focused largely on suppressing the immune
reaction induced by the donor cells derived from the hematopoietic stem
cell graft against the host and have remained clinically unsuccessful in
most cases, with mortality rates around 80% after twelve months in
steroid-resistant cases. Patients with hematological malignancies
receive multiple courses of chemotherapy, antibiotics, and ultimately
conditioning before HSCT, which are known to severely impact the gut
microbial composition.

About MaaT013

MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema
formulation manufactured using MaaT Pharma’s integrated Microbiome
Restoration Biotherapeutic (MMRB) platform. The product has a stability
of up to 24 months and is characterized by a high diversity and
consistent richness of microbial species derived from pooled healthy
donors and manufactured at the company’s centralized European cGMP
production facility. MaaT013 has been granted Orphan Drug Designation by
the US Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) and is already being administered in compassionate use.

About MaaT Pharma

MaaT Pharma, a clinical stage company, has established the most complete
approach to restoring patient-microbiome symbiosis to improve survival
outcomes in life-threatening diseases. Committed to treating blood
cancers and graft-versus-host disease, a serious complication of
allogeneic stem cell transplantation, MaaT Pharma has already achieved
proof of concept in acute myeloid leukemia patients. Supporting the
further expansion of our pipeline into larger indications, we have built
a powerful discovery and analysis platform to evaluate drug candidates,
determine novel disease targets and identify biomarkers for
microbiome-related conditions. Our therapeutics are produced through a
standardized cGMP manufacturing and quality control process to safely
deliver the full diversity of the microbiome. MaaT Pharma benefits from
the commitment of world-leading scientists and established relationships
with regulators to spearhead microbiome treatment integration into
clinical practice.

Contacts

For MaaT Pharma
Hervé Affagard, CEO
Phone: +33 (0)4
2829 1400
E-Mail: [email protected]

Media Requests for MaaT Pharma
Dr. Stephanie May or Dr.
Jacob Verghese
Trophic Communications
Phone: +49 89 23 88 77
30 or +49 171 185 56 82
E-Mail: [email protected]
or [email protected]