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The US FDA Lifts Clinical Hold for MaaT Pharma’s MaaT013 to Treat Acute Graft-versus-Host Disease

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MaaT Pharma

The US FDA Lifts Clinical Hold for MaaT Pharma’s MaaT013 to Treat Acute Graft-versus-Host Disease

Shots:

  • The US FDA has lifted the clinical hold & cleared the IND application to initiate the P-III trial evaluating MaaT013 in patients with aGvHD in the US
  • To bring MaaT013 to US patients, the company plans to consult with the US FDA about the following regulatory steps. The company also continues MaaT013's late-stage clinical development in the EU
  • MaaT013, a full-ecosystem, off-the-shelf, standardized, pooled-donor, Microbiome Ecosystem Therapy received ODD from the US FDA & EMA. MaaT013 aims to correct the responsiveness & tolerance of immune functions, reduce steroid-resistant, gastrointestinal-predominant aGvHD, and restore the symbiotic relationship b/w the patient's functional gut microbiome & immune system

Ref: Businesswire | Image: MaaT Pharma

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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