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MaaT Pharma Announces Positive Topline Results from Phase 2 HERACLES Clinical Trial

 

MaaT Pharma Announces Positive Topline Results from Phase 2 HERACLES Clinical Trial with Lead Microbiome Ecosystem Therapy MaaT013 in Patients with Acute Graft-versus-Host Disease

 

  • Study meets primary and key secondary objectives with positive impact and favorable overall safety profile in 21 heavily pre-treated and immunocompromised patients with steroid-resistant, gastrointestinal-predominant aGvHD following stem cell transplantation
  • Results in line with previously observed data from a larger patient population treated with MaaT013 as part of an early access program
  • MaaT013 expected to advance into pivotal Phase 3 program

 

Lyon, France, March 17, 2021 – MaaT Pharma announced today positive topline results from its Phase 2 clinical trial evaluating lead microbiome ecosystem therapy, MaaT013, in a high-risk patient population with grade III-IV steroid-refractory, gastrointestinal-predominant acute graft-versus-host disease (SR-GI-aGvHD). The study met its primary endpoint of clinical efficacy, demonstrating a combined 33.3% complete response rate (CR) or very good partial response rate (VGPR) at day 28. In addition, the overall response rate (ORR) was 38.1% at day 28 and the best overall response rate (BORR), i.e. the number of patients achieving a response at any point up to day 28, was 57.1%. MaaT013 also showed an acceptable safety profile.

 

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