Clinical Trial Details
— Status: Available
Administrative data
| NCT number |
NCT04768907 |
| Other study ID # |
MPOHEAP |
| Secondary ID |
|
| Status |
Available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
July 2023 |
| Source |
MaaT Pharma |
| Contact |
Emilie Plantamura, PharmD, PhD |
| Phone |
+33(0)663590186 |
| Email |
eplantamura[@]maat-pharma.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial Summary
MaaT013 is still in clinical development phase and is not approved yet for marketing in any
region. During the development program, MaaT Pharma has undertaken initial development with
closely related product candidates, leading to the Phase II HERACLES study in which MaaT013
preliminary safety and efficacy were assessed in the context of steroid-resistant,
gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III
study (ARES trial) is planned.
In the absence of medical options in patients with gastrointestinal acute GvHD refractory to
multiple lines of treatment, this early access program has been implemented.
Description:
Acute Graft-versus-Host Disease (aGvHD) is a serious and life-threatening disease that arises
as a complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT). At the
onset of aGvHD, skin is the most frequently affected region (80% of patients) while GI tract
or liver are involved in about 50% of patients (Martin 1990). aGvHD symptoms for the lower GI
tract include watery diarrhea (≥500 mL), severe abdominal pain or bloody diarrhea (Ferrara
2009). While the incidence of severe GI-aGvHD has slightly decreased during the past decade,
treatment remains unsuccessful in most cases (Gooley 2010, Castilla Llorente 2014), with a
2-months overall survival (OS) rate of 22% in steroid non-responsive or steroid refractory
(SR) patients, non-responders to ruxolitinib (Jagasia 2020).
MaaT013 (pooled allogeneic fecal microbiota) is a live biotherapeutic product being developed
by MaaT Pharma (Lyon, France) for the treatment of steroid-resistant, gastrointestinal aGvHD
(SR-GI-aGvHD) adult patients with refractory, not eligible or who have failed second-line
systemic therapy.
MaaT013 is still in clinical development phase and is not approved yet for marketing in any
region. During the development program, MaaT Pharma has undertaken initial development with
closely related product candidates, leading to the Phase II HERACLES study in which MaaT013
preliminary safety and efficacy were assessed in the context of SR-GI-aGvHD. In addition, a
pivotal Phase III study (ARES trial) is planned
