MaaT Pharma Releases Results Of Microbiome Restoration Therapy in Acute Myeloid Leukemia Patients

• Microbiome diversity returned 10 days after FMT administration
• The therapy appeared to have an anti-imflammatory impact

AML standard intensive induction chemotherapy combined with wide spectrum antibiotics can dramatically alter the composition of the gut microbiota, leading to dysbiosis which is characterized by loss of microbial diversity. Such dysbiosis status can promote a pathological condition involving uncontrolled local immune responses, systemic inflammation and increased incidence of adverse events. In this Ph I/II study MaaT evaluated the use of autologus FMT (fecal microbiota transplant) to restore patients' gut microbiome following treatment.

At the time of diagnosis, patients feces were collected, screened and stored at -80C. After hematopoietic recovery (S2) and before consolidation chemotherapy the feces were administered as an enema. The primary endpoint was the recovery of at least 70% of microbiota diversity (based on the Simpson index) after administration and the reduction of multidrug resistant bacteria carriage.

Induction chemotherapy induced a dramatic shift in microbial communities, with a significant 42.3% decrease of mean α-diversity Simpson index at species level (0.85 to 0.50; p<0.001). Ten days after FMT administration (S3), the Simpson index returned to its initial baseline level (0.50 to 0.86; p<0.001).

There were no serious adverse events associated with FMT and the therapy did not induce any systemic inflammatory reaction (as measured by fecal and blood markers). The restoration of the patients' microbiome diversity actually resulted in a reduction of fecal and blood markers of inflammation – suggesting that FMT may have an anti-inflammatory impact.

The results of the study will be presented at the ASH Annual Meeting on December 1, 2018.