- New collection campaign to support future clinical development of microbiome biotherapeutic product portfolio and to supply the French compassionate use program in acute Graft-vs-Host-Disease (aGvHD)
- Planned initiation follows ANSM (French National Agency for the Safety of Medicines and Health Products) decision today to lift [1] the “Décisions de Police Sanitaire” [2] (“Health Policy Decision”) of March 13th, March 16th and March 24th related to the collection of stools during the COVID-19 pandemic
- The lift results in a two-step approach enabling microbiome stakeholders to move forward with immediate collection, preparation and storage; collected material will be quarantined until further recommendations are, where appropriate, provided by the agency
Lyon, France, August 20, 2020 – MaaT Pharma announced today it plans to initiate a new collection and manufacturing campaign to be completed in the second half of 2020 for the production of its microbiome biotherapeutics, enema formulation MaaT013 and capsule formulation MaaT033. This decision follows the announcement by ANSM1 (French National Agency for the Safety of Medicines and Health Products) to repeal its earlier decisions made on March 13, March 16, and March 24 2020, “Décisions de Police Sanitaire” (“Health Policy Decisions”, DPS)2 that related to the collection and use of fecal microbiota products during the COVID-19 pandemic. Based on this ANSM decision, collection of fecal microbiota can resume for all uses (bulk compounding, hospital compounding and medicine production), following certain additional guidelines. Raw and manufactured material will be placed under quarantine until potential additional protection measures are communicated, which may trigger retrospective screening before release. The ANSM decision is the result of a discussion forum initiated with all relevant stakeholders on August 10th, 2020.
“There remains a significant medical need for new drug modalities in patients with severe conditions and resuming our sample collection and manufacturing activities enables us to continue to develop our microbiome biotherapeutics for these patients. The French private and public microbiome ecosystem benefits from the global leadership position ANSM has established, since 2014, in developing a regulatory framework for live biotherapeutic products,” commented Hervé Affagard, Co-founder and CEO of MaaT Pharma. “Our goal is to provide the most appropriate microbiome-based biotherapies to patients to improve treatment outcomes in oncology and our ongoing dialogue with regulators worldwide is of the utmost importance to ensure both the safety and quality of our products.”
The decision by ANSM enables companies, hospitals and academic institutions in France to resume collection of stools to manufacture microbiota-related products, while following specific SARS-CoV-2- testing-related guidelines. In conjunction with this, MaaT Pharma has implemented new protocols and screening measures that are compliant with all ANSM guidance related to COVID-19 to protect our patients, stool donors, partners and staff from the risk of infection and transmission.
The new donor stool collection and manufacturing campaign will support further clinical development of MaaT Pharma’s proprietary pipeline of live biotherapeutic products MaaT013 and MaaT033, as well as the preexisting compassionate use program in France, called Autorisation Temporaire d’Utilisation Nominative (ATUn), previously granted to MaaT013 by ANSM for the treatment of acute Graft-vs-host-Disease (aGvHD). MaaT013 is a biotherapy characterized by consistent richness of microbial species, derived from pooled healthy donors, and developed to restore immune homeostasis to treat life-threatening diseases; MaaT013 is currently in Phase 2 clinical development for the treatment of aGvHD. MaaT033 is an oral formulation of MaaT013 and is expected to enter clinical testing in patients with acute myeloid leukemia before year end.
About MaaT Pharma
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients and a Phase 2 clinical trial in acute GvHD is ongoing. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform, GutPrint®, to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.