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
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