MaaT013 Re-Examination Initiated
MaaT Pharma Seeks Re-Examination of MaaT013 After Negative EU Drug Opinion
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MaaT Pharma announced plans to request a re-examination after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on MaaT013, a microbiome therapy for acute Graft-versus-Host Disease (aGvHD). The drug, proposed under the brand name Xervyteg®, would have been the first-ever microbiome-based therapy approved in Europe for this indication, according to Business Wire.
The CHMP opinion was a setback for Lyon-based MaaT Pharma, whose stock trades on Euronext Paris. But the company is not giving up. It will formally request re-examination, triggering a new 60-day review window once the request is validated, according to Yahoo Finance.
What aGvHD Is and Why This Drug Matters
Acute Graft-versus-Host Disease is a life-threatening complication of bone marrow transplants. Donor immune cells attack the patient's own body. Standard treatment uses steroids, but 30–50% of patients do not respond to them. For those patients, six-month mortality rates can reach 80%, according to Business Wire.
MaaT013 is not a simple probiotic. It is a "Microbiome Ecosystem Therapy" made from the gut bacteria of over 80 healthy donors. It aims to restore immune balance in the gut. In a Phase 2 trial, MaaT013 showed a 63% overall response rate at day 28 in patients with gut-specific aGvHD, according to Barchart.
Why the CHMP Said No and What Happens Next
The CHMP's negative opinion likely reflects concern about the strength of the data. MaaT Pharma applied under a Conditional Marketing Authorization (CMA) pathway. This route is meant for drugs with strong unmet need but incomplete data. The committee appears to prefer waiting for results from the ongoing Phase 3 ARES trial rather than relying on Phase 2 and early access data, according to Yahoo Finance.
MaaT Pharma must formally notify the EMA of its re-examination request within 15 days of the negative opinion. Once validated, the CHMP has 60 days to issue a new assessment. The company will request a new rapporteur, a new co-rapporteur, and a Scientific Advisory Group (SAG) hearing with hematology experts, according to Business Wire.
The Scientific Advisory Group Is MaaT Pharma's Key Move
Requesting a SAG hearing is a deliberate strategy. The SAG brings in independent hematology experts who can speak directly to the clinical urgency of aGvHD. MaaT Pharma wants these experts to tell the CHMP that waiting for Phase 3 data means patients die without options. The company argues that data from over 100 patients treated in early access programs already show real-world benefit, according to Business Wire.
Historically, the CHMP rarely reverses its own opinions. But the appointment of new rapporteurs gives MaaT Pharma a genuine second chance to address specific technical concerns. If the re-examination fails, the company will likely need to wait for Phase 3 ARES trial results, expected in late 2025, delaying any European approval by 18 to 24 months, according to Yahoo Finance.
Patients Can Still Access MaaT013 During the Review
MaaT Pharma confirmed that MaaT013 remains available to eligible patients during the re-examination period. In France, patients can access the drug through the "Autorisation d'Accès Compassionnel" system — a compassionate use framework for serious conditions with no approved treatment. This keeps the drug in patients' hands while regulators deliberate, according to Business Wire.
Beyond aGvHD, MaaT Pharma is also expanding its microbiome research into immuno-oncology — using gut bacteria to improve cancer patients' immune responses to treatment. The company reported holding over €40 million in cash as of mid-2024, giving it some financial runway to absorb the cost of a prolonged regulatory process, according to Barchart.
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