Business Update

PR FDA Safety Alert

By March 13, 2020 No Comments
  • In response to the recent “FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms,” MaaT Pharma wants to reassure patients, their families, treating physicians and health authorities across the globe that we continuously and rigorously test our biotherapeutics – at least to the highest standards of the industry, often exceeding them.

 

  • Regarding the specific, pathogenic coli types associated with the recently reported serious adverse events, enteropathogenic Escherichia coli(EPEC) and Shigatoxin-producing Escherichia coli (STEC), the French health authority (ANSM) requires in their recommendations for FMT donations to test donors for E. coli producing shigatoxins (STEC), using PCR. MaaT Pharma, since 2017, already tests donors every 7 days for the absence in their stools not only of this specific E. coli, but also of EPEC and additional pathogenic E. coli.

 

  • MaaT Pharma’s investigational drugs are currently being clinically tested in hemato-oncological patients with intestinal-predominant acute graft-versus-host disease in a phase 2 clinical trial in Europe and under a compassionate use program in France.

 

  • No infection of the above-mentioned kind has been reported up to today (March 2020), and the required Drug Safety Monitoring Board reviews have consistently approved to continue our clinical trials without protocol amendments, underlining the overall safety of our biotherapeutics.

 

  • The recent events in the US are a call to action for everybody working in the nascent field of microbiome-related therapies to continue focusing on patient safety as we commit to the highest standards of product review, quality control, approved product processing and manufacturing processes as we work together with regulatory bodies to continue improving and updating monitoring and testing standards in the path towards approval of microbiome therapeutics.

Chief Medical Officer of MaaT Pharma