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MaaT Pharma Treats First U.S. Patient with Microbiome-Based Therapy for Refractory aGvHD

MaaT Pharma administers MaaT013 to the first U.S. patient with refractory aGvHD under FDA compassionate use, offering new hope.

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  • Dec 06, 2024

  • Mrudula Kulkarni

MaaT Pharma Treats First U.S. Patient with Microbiome-Based Therapy for Refractory aGvHD

Clinical stage biotech company with its novel approach focused on Microbiome Ecosystem Therapies™, MaaT Pharma has successfully treated the first acute Graft-versus-Host Disease (aGvHD) patient in the United States under the FDA’s Single Patient Expanded Access program. The treatment was at the City of Hope Cancer Centre in Los Angeles, and it was managed by Dr. Monzr M. Al Malki and Dr. Ryotaro Nakamura, who are well experienced in hematopoietic cell transplantation and GvHD. The patient had a history of prior treatments with steroids and molecular targeted therapy through ruxolitinib with no improvement recorded earlier. Compassionate use is known as extended access as it provides a ray of hope to the patients suffering from life-threatening diseases who usually possess no other ways to go through with it.


Dr. Nakamura seemed optimistic about the compound, saying, “It will be a great asset for the clinic to have MaaT013 for this patient’s management of refractory aGvHD.” In a similar comment, Dr. Al Malki said that such a microbiome immune modulation approach presents a hopeful means of addressing complicated aGvHD patients. The importance of this development was not lost on the company’s CEO and co-founder Hervé Affagard, who noted that ‘providing MaaT013 under CU in the U.S. underlines the desperate need for new therapies for refractory aGvHD worldwide and offers hope to those patients fighting this debilitating condition.’


The global operations of MaaT Pharma are however on an upward trend, with the MaaT013 phase 3 trial in Europe almost complete and trials in the U.S. next. Interim results for the European study are expected in January 2025, and a Phase 3 trial for aGvHD with primary refractory GI aGvHD patients and those intolerant of ruxolitinib in the United States is being proposed. Likewise, further data from the European Early Access Program of MaaT013 will be delivered at the ASH 2024 Annual Meeting early the following year in San Diego, California. These advances place MaaT013 as a light at the end of the tunnel for patients and clinicians seeking improved results in the management of aGvHD.

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