MaaT Pharma,a French oncology company, said that it has dosed the first patient in the HERACLES phase 2 trial of MaaT013, a microbiome restoration candidate, in patients with steroid-resistant acute Graft-versus-Host-Disease (SR-aGvHD).
aGvHD is considered to be one of the major causes of death after an allogeneic stem cell transplant because of attack of the transplanted immune cells on the patient’s tissues. The disease leads to a very dismal outcome and poor overall survival in patients who do not respond to first line therapy as there are no available second-line treatments.
MaaT Pharma claims that MaaT013 is characterized by its high microbial diversity and richness that can restore the functional microbiome of patients with the aimof re-establishing homeostasis.
Herve Affagard – Co-founder and CEO of MaaT Pharma, commenting on HERACLES phase 2 trial of MaaT013, said: “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 of MaaT013 is a multi-center study held across four European countries which has enrolled patients who had first-line standard treatment of corticosteroids after allogeneic hematopoietic stem cell transplantation.
According to MaaT Pharma, the enema formulation MaaT013 will be administered to the patients at Day 2, 9 and 16 of the treatment period, which would last for 28 days.
The French oncology company says that the primary endpoint of the HERACLES phase 2 trial of MaaT013 is to get gastro-intestinal and overall GvHD response by day 28 post-inclusion.
Patient follow-up will be carried out six months and 12 months following inclusion, said MaaT Pharma.
Commenting on HERACLES phase 2 trial of MaaT013, Professor Mohamad Mohty -international coordinator of the trial said: “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.”