Clinical Trials

Date: 2022-03-28

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: Maat Pharma (France)

Product: MaaT013

Action mechanism: microbiome-based therapy. MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, Microbiome Ecosystem Therapy (MET). It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the FDA and the EMA. MaaT013 is made of allogeneic, full-ecosystem pooled biotherapeutic intestinal microbiota manufactured by MaaT Pharma in Lyon, France, according to GMP requirements. The intestinal microbiota material in its natural environment is derived from healthy, strictly-vetted and selected donors, following the European consensus recommendations (Cammarota 2016) with the purpose of minimizing the risk associated with fecal material transplants (FMT) for clinical research. Thus, prior to donation, donors undergo a thorough medical evaluation and laboratory screening including SARS-CoV-2 detection, to avoid any known contamination risk. MaaT013 is administered as an enema.

Disease: steroid-resistant gastrointestinal acute graft-versus-host disease (SR GI-aGvHD)

Therapeutic area: Transplantation

Country: France

Trial details: ARES is an open-label, single-arm Phase 3 study (NCT04769895),which evaluates the safety and efficacy of MaaT013, Maat Pharma’s high-richness, high-diversity lead Microbiome Ecosystem Therapy (MET) as a third-line, salvage therapy in GI-aGvHD patients. 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.

Latest news:

* On March, 28, 2022, MaaT Pharma, 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 ruxolitinib[1] used as a second-line treatment.
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.

Is general: Yes