Phase II HERACLES trial meets its primary objective

On March 17, 2021, it was announced that the phase II HERACLES trial (NCT03359980), evaluating MaaT013 in patients with acute graft-versus-host disease (aGvHD), met its primary objective.

This multi-center, single-arm, open-label study evaluated the efficacy and safety of MaaT013, a standardized, high-diversity, pooled-donor microbiome biotherapeutic, in 21 heavily pretreated patients with steroid-refractory Grade III─IV gastrointestinal-predominant aGvHD.

These patients received at least one (and up to three) doses of MaaT013; responses were evaluated 7 days after each administration and on Day 28 after the first dose. The primary endpoint of clinical efficacy was met, with a complete response/very good partial response rate of 33.3% at Day 28. In addition, the overall response rate was 38.1% at Day 28 and the best overall response rate up to Day 28 was 57.1%. The safety profile of MaaT013 was good, with no increase in drug-related infection rates observed in this heavily pretreated and immunocompromised population.

These results were in line with data from the expanded access program, reported here. Based on these positive results, MaaT013 is expected to advance into a pivotal phase III trial.

For further information, watch our recent interview with Florent Malard.