MaaT Pharma Begins Treatment for Acute Graft-versus-Host Disease

MaaT Pharma Begins Treatment for Acute Graft-versus-Host Disease

In a groundbreaking development, MaaT Pharma, a clinical-stage biotechnology company known for its innovative microbiome therapies, has initiated treatment for its first U.S. patient diagnosed with acute Graft-versus-Host Disease (aGvHD). This milestone comes as part of the U.S. Food and Drug Administration's (FDA) Single Patient Expanded Access program, which allows exceptional cases where patients may benefit from investigational treatments when other options are unavailable.

Compassionate Use and Its Importance

The FDA's Expanded Access program, often referred to as compassionate use, presents a pathway for patients with serious or life-threatening conditions to access investigational medical products. These options are available when other satisfactory treatments are ineffective or nonexistent. In this case, a treating physician in the United States has successfully petitioned for access to MaaT013 to aid a patient previously treated with several therapies, including steroids and ruxolitinib.

Treatment at City of Hope

The patient received their treatment at City of Hope, a premier cancer research and treatment center recognized as one of the top five cancer hospitals in the U.S. by U.S. News & World Report. Leading the procedure were esteemed physicians Monzr M. Al Malki, M.D., and Ryotaro Nakamura, M.D., both of whom are renowned in the field of Hematopoietic Cell Transplantation and aGvHD management.

Positive Outlook from Medical Experts

Dr. Nakamura expressed enthusiasm about the potential of MaaT013, stating, “We are excited to have access to MaaT013 for this patient for the treatment of refractory aGvHD.” Dr. Al Malki echoed this positivity, emphasizing the belief that microbiome-based immune modulation could significantly enhance outcomes for patients suffering from aGvHD.

The Significance of MaaT013

MaaT013 represents a revolutionary approach in the treatment of aGvHD. As a standardized, pooled-donor Microbiome Ecosystem Therapy, MaaT013 aims to restore the balance between a patient’s gut microbiome and immune response, specifically targeting the challenges associated with gastrointestinal-involved aGvHD. It has received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA), highlighting its importance in addressing this debilitating condition.

Future Developments and Clinical Trials

MaaT Pharma is diligently progressing with its Phase 3 ARES clinical trial in Europe. With patient recruitment now complete for this trial, topline results are anticipated shortly. Furthermore, plans are in place to launch a U.S.-based Phase 3 clinical trial targeted at evaluating MaaT013 specifically for patients with gastrointestinal aGvHD resistant to standard treatments like ruxolitinib.

Contributions to Global Health

Hervé Affagard, CEO and co-founder of MaaT Pharma, highlighted the global necessity for innovative therapies, stating, “Providing MaaT013 under compassionate use in the U.S. reflects the pressing need for effective treatments for refractory aGvHD.” The company’s efforts not only generate hope for patients in dire circumstances but also expand the reach of their groundbreaking microbiome-driven therapies.

About MaaT Pharma

MaaT Pharma, founded in 2014 and based in Lyon, France, specializes in developing unique gut microbiome-driven therapies aimed at improving the immune system and enhancing patient survival rates in oncology. The company applies proprietary technologies for pooling and co-cultivating donor microbiomes, transforming these into high-diversity, standardized drug candidates. Trading under ticker MAAT on Euronext Paris since 2021, MaaT Pharma continues to lead in this innovative treatment arena.

About MaaT013

MaaT013 is distinguished as a full-ecosystem, off-the-shelf microbiome therapeutic specifically designed for acute, hospital use. It boasts a diverse range of microbial species and is underpinned by Butycore, a group of bacteria producing essential anti-inflammatory metabolites. By fostering a symbiotic relationship between the gut microbiome and immune system, MaaT013 endeavors to improve outcomes for patients suffering from steroid-resistant and GI-predominant aGvHD.

Frequently Asked Questions

What is the FDA's Expanded Access program?

The FDA's Expanded Access program, also known as compassionate use, allows patients with serious or life-threatening conditions to access investigational medical treatments when no satisfactory alternatives are available.

What condition is MaaT013 being used to treat?

MaaT013 is being administered for the treatment of acute Graft-versus-Host Disease (aGvHD), particularly in patients unresponsive to standard therapies.

Where was the first U.S. treatment of MaaT013 performed?

The first U.S. patient treated with MaaT013 received the therapy at City of Hope, a leading cancer research institute.

What are the future plans for MaaT013?

MaaT Pharma plans to initiate a U.S. Phase 3 clinical trial and present additional data from its European Early Access Program at the upcoming ASH Annual Meeting.

What is the goal of MaaT Pharma?

MaaT Pharma aims to develop innovative microbiome-driven therapies that enhance cancer treatment outcomes and improve the survival of patients with severe conditions.

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