MaaT Pharma commences HERACLES Phase 2 trial for MaaT013 in battle against acute graft-versus-host disease

MaaT Pharma, a French oncology company, has announced a significant milestone in its clinical research: the dosing of the first patient in the HERACLES Phase 2 trial for MaaT013, a microbiome restoration therapy. This trial targets steroid-resistant acute Graft-versus-Host-Disease (SR-aGvHD), a severe complication following allogeneic stem cell transplants.

Acute Graft-versus-Host-Disease (aGvHD) is a major cause of mortality after such transplants. It arises when transplanted immune cells attack the recipient’s tissues, leading to poor outcomes and high mortality rates in cases that do not respond to standard treatments. Currently, there are no second-line therapies available, highlighting the critical need for innovative solutions.

MaaT013 is characterized by its high microbial diversity and richness, designed to restore the functional microbiome in patients with aGvHD. The goal is to re-establish microbiome homeostasis and improve patient outcomes.

Hervé Affagard, Co-founder and CEO of MaaT Pharma, emphasized the significance of this trial: “The dosing of the first patient in our clinical trial, called HERACLES, marks an important milestone in MaaT Pharma’s objective to improve survival outcomes in patients undergoing allogeneic stem cell transplantation. Our strategy is to demonstrate that re-establishing healthy microbial networks in the gut can restore patient-microbiome symbiosis, which improves the patient’s ability to recover and increase their chance of survival.”

The HERACLES Phase 2 trial is a multi-center study conducted across four European countries. It involves patients who have received standard corticosteroid treatment as their first-line therapy after allogeneic hematopoietic stem cell transplantation. MaaT013, administered as an enema, will be given to patients on Days 2, 9, and 16 over a 28-day period.

The primary endpoint of the trial is to evaluate gastrointestinal and overall GvHD response by Day 28 post-inclusion. Patient follow-ups will be conducted at six months and twelve months following inclusion in the study.

Professor Mohamad Mohty, the international coordinator of the trial, highlighted the potential impact of restoring microbial diversity: “The diversity and complex interactive networks in the microbial ecosystem within the patient are greatly compromised during the occurrence of severe aGvHD, and restoring it has the potential to achieve therapeutic impact on survival. An accumulating body of evidence is corroborating our approach and we look forward to further validating the concept in this controlled European study.”