MaaT Prepares For EMA Filing, US Expansion After Positive GVHD Readout

The French biotech plans to file for EMA approval in graft-versus-host disease in mid-2025 while starting a US Phase III trial, which the CEO said in an interview is contingent on financing.

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MaaT Pharma is planning to first target the European market with MaaT013 for acute graft-versus-host disease with gastrointestinal involvement (GI-aGVHD) as it seeks to raise money to bring its microbiome-based drug to the US market.

The Lyon, France-based biotech company announced 8 January data from the single-arm, open-label Phase III ARES trial, testing the drug as a third-line treatment among patients refractory to steroids and...

Key Takeaways

MaaT announced positive results from its Phase III ARES trial of MaaT013 in acute graft-versus-host disease with gastrointestinal involvement, including a 64% overall response rate.

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