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.
“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.
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Contacts
For MaaT Pharma
Hervé Affagard, CEO
Phone: +33 4 2829 1400
E-Mail: haffagard@maat-pharma.com
Media Requests for MaaT Pharma
Gretchen Schweitzer or Laura Mittmann
Trophic Communications
Phone: +49 89 2388 7731
E-Mail: maat@trophic.eu
Source: MaaT Pharma
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