MaaT Pharma Announces First Patient Dosed in Phase 3 ‘ARES’ Trial Evaluating MaaT013 in Patients with Acute Graft-vs-Host-Disease
Pivotal Phase 3 clinical trial investigates the efficacy of lead Microbiome Ecosystem Therapy MaaT013 as third-line treatment in patients with steroid-resistant gastrointestinal acute Graft-versus-Host Disease (SR GI-aGvHD)
ARES is the first Phase 3 trial globally for a microbiome-based therapy in haemato-oncology
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, announced that the first patient has been dosed in its pivotal Phase 3 trial investigating MaaT013 in patients with acute Graft-versus-Host-Disease with gastrointestinal involvement (GI-aGvHD) who are refractory to both steroids, the standard of care first-line treatment, and to ruxolitinib1 used as a second-line treatment. The open-label, single-arm Phase 3 study (NCT04769895), called ‘ARES’, evaluates the safety and efficacy of MaaT013, the company’s high-richness, high-diversity lead Microbiome Ecosystem Therapy (MET) as a third-line, salvage therapy in GI-aGvHD patients2. aGvHD is a severe complication of an allogeneic stem cell transplant and every year, approximately 10,000 patients are diagnosed globally.
“Initiating the pivotal Phase 3 trial with our lead candidate MaaT013 is an important milestone for our company and for the microbiome therapeutics field worldwide. If ARES is successful, we believe this study could serve as the basis for MaaT013’s approval in this severe indication with a very high unmet need,” said Hervé Affagard, co-founder and CEO of MaaT Pharma.
ARES is a Phase 3 multicenter, international, open-label, single-arm study assessing the safety and efficacy of MaaT013 in 75 patients with Grade II-IV GI-aGvHD who are refractory to steroids and are resistant or are intolerant to ruxolitinib. The clinical trial will be conducted in up to 40 different sites across the European Union. To date, the company has received regulatory approvals from France, Germany and Spain, and the clinical trial may also be expanded to sites in the United States subject to regulatory approval. Eligible patients in the ARES study will be administered a total of 3 doses of MaaT013 as an enema formulation over a period of 10 days. The primary endpoint of the study is the GI-overall response rate (GI-ORR) to MaaT013 treatment at day 28. Secondary endpoints include the safety and tolerability of MaaT013 up to 12 months, as well as overall survival after 12 months. A first data review is expected in Q1 2023 after enrollment of half the patients in the study.
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Prof. Mohamad Mohty, Professor and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University and past-president of the European Society for Blood and Marrow Transplantation (EBMT) added, “The medical need is extremely high for GI-aGvHD patients who are refractory to both steroids and ruxolitinib, as they face an 80% mortality rate within the first few months3. By restoring the gut microbiome ecosystem, MaaT013 opens a brand-new therapeutic modality and provides a strongly differentiated, immuno-restorative approach that may complement standard immunosuppressive drugs and may provide a breakthrough for patients with no other therapeutic options.”
The Phase 3 ARES trial builds on previously shared positive results from the company’s Phase 2 HERACLES study of MaaT013 (n= 24) and from data of 52 patients benefiting from an ongoing early access program with MaaT013 in France. Both clinical datasets demonstrated that MaaT013 was generally well tolerated in this heavily immunocompromised patient population and demonstrated promising clinical benefit, which translated into a positive impact on overall survival rates in patients responding to the treatment. To date, more than 100 patients with aGvHD have been safely treated with MaaT013.
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