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MaaT’s FDA Woes Highlight Rocky Regulatory Path For Microbiome-Based Therapies

Clinical Hold Remains On Graft-Versus Host Disease Drug

 
• By Kevin Grogan

The French firm's lead microbiome therapy has been on clinical hold in the US for a year and continuing concerns about MaaT's 'pooling' approach (mixing donations from multiple donors) suggests the wait to restart trials will not be a short one.

• Source: Shutterstock

The promise of microbiome-based therapeutics to treat a variety of diseases is considerable but so too are the concerns of regulators about a new class of drugs, as France's MaaT Pharma SA has once again found out.

MaaT listed on the Euronext Paris in November last year, making much of the potential of MaaT013, its lead candidate for acute graft-versus host disease (aGvHD) in patients who have undergone allogeneic hematopoietic cell transplants

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