MaaT Pharma has dosed the first patient in a Phase II clinical trial of MaaT013 for the treatment of patients with steroid-resistant acute SR-aGvHD.
The open-label, prospective multi-centre, single group assignment trial is expected to recruit 32 patients who have received a first-line standard treatment of corticosteroids following allogeneic hematopoietic stem cell transplantation.
MaaTPharma co-founder Hervé Affagard 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."
The trial is being conducted across four countries in Europe. MaaT013 will be given at day two, nine and 16 of the 28-day treatment period.
The trial’s primary objective is to achieve gastro-intestinal and overall GvHD response by day 28 post-inclusion.
Its secondary objectives comprise safety of fecal microbiota transfer (FMT) in the patients, as well as the number of patients with infectious disorders such as chronic GVHD.
Patients will be followed-up for six months and 12 months after inclusion.
HERACLES trial international coordinator Mohamad Mohty 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.”
SR-aGvHD is a deadly complication in patients who have undergone allogenic hematopoietic stem cell transplantation.
In addition, aGvHD is a major reason of death after an allogeneic stem cell transplant due to the transplanted immune cells attacking the patient’s tissues.
The disease leads to a very negative outcome and poor overall survival in patients not responding to first-linest line therapy. Currently, there is no second-line of treatments available for aGvHD.
MaaT Pharma’s lead candidate MaaT013 contains several high microbial that can restore the patients' functional microbiome with the aim of re-establishing homeostasis.