MaaT Pharma Announces Update on US FDA Investigational New Drug Application for MaaT013 in Patients with Acute Graft-vs-Host Disease
Lyon, France–(BUSINESS WIRE)–Maat Pharma (EURONEXT: MAAT – the “Company”), French clinical-stage biotech and pioneer in the development of Microbiome Ecosystem TherapiesMT (MET) dedicated to improving survival outcomes for cancer patients, today announced that it has received a communication from the United States Food and Drug Administration (“FDA” or “the Agency”) regarding the company’s Investigational New Drug (IND) application filed in June 2021 for to initiate a single-arm Phase 3 clinical trial of the Company’s drug candidate, MaaT013, in the United States in patients with steroid-resistant acute graft-versus-host disease (aGvHD). Following questions raised by the FDA in August 2021 on this request in a clinical hold letter, the Company had previously submitted a request for a Type A meeting, along with detailed responses to the Agency’s questions.
A response letter was received on the evening of August 8e, 2022, Central European Time (CET). It indicates that the Agency maintains the clinical suspension of MaaT013 in the United States and details the FDA’s position on the clinical trial. The Agency acknowledges that it has received satisfactory responses from the Company on multiple clinical and manufacturing-related questions that it had initially raised. However, the Agency wishes to obtain additional information, in particular on the safety and effectiveness of the Company’s “pooling” approach (that’s to say mix donations from multiple donors to achieve greater richness, diversity and better product standardization). The Society is also evaluating additional recommendations made by the Agency regarding the design of the trial.
“We appreciate the FDA’s continued commitment as we seek to expand the Phase 3 clinical trial of MaaT013 in the United States. and we intend to work with the Agency to resolve the issues raised in the communication, while implementing a defined strategic plan to continue to meet our milestones,” said Hervé Affagard, CEO and co-founder of MaaT Pharma. “To date, data collected from over 120 patients with aGvHD who have received MaaT013 in Europe through our early access program in France and our completed Phase 2 trial in Europe, have indicated a profile positive safety and efficacy for MaaT013. We remain focused on bringing innovative and safe microbiome therapies to patients with refractory aGvHD.
MaaT Pharma is currently preparing the next steps for the interaction with the FDA, potentially including a Type A meeting dedicated to discussing the remaining issues. In parallel and in line with its goal of reaching patients worldwide, the Company will continue the development of MaaT013 in Europe and expand European recruitment for its ongoing phase 3 trial evaluating MaaT013 in 75 patients. There are currently 19 active clinical sites in France, Germany and Spain and the Company has submitted clinical trial applications in three other European countries. The overall timelines for the Phase 3 trial and, if approved, commercialization of MaaT013 in Europe remain unchanged.
In parallel, the Company continues to prepare the launch of a phase 2/3 trial in Europe to evaluate its second native active ingredient (derived from a donor), MaaT033, in patients with blood cancers receiving an allograft of cells hematopoietic strains (allo-HSCT) . This clinical study is expected to begin in the fourth quarter of 2022.
The Company is also continuing to prepare a first human trial of its first candidate MaaT03X co-fermented in Europe and the United States. This novel class of drug candidates aims to improve the anticancer efficacy of immune checkpoint inhibitors in undisclosed solid tumor patients with high unmet need.
About MaaT Pharma
MaaT Pharma, a clinical-stage biotechnology company, has implemented a comprehensive approach to restore the patient-microbiome symbiosis in oncology. Committed to the treatment of cancer and graft versus host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma launched, in March 2022 in Europe, a phase 3 clinical trial for patients with acute GvHD, following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, supports the development and expansion of its pipeline by determining new disease targets, evaluating drug candidates and identifying biomarkers for microbiome-related conditions. The Company’s microbiome ecosystem therapies are produced under a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-renowned scientists and established relationships with regulators to support the integration of the use of microbiome therapies into clinical practice.
MaaT Pharma is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).
All statements other than statements of historical facts included in this press release regarding future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. Such statements may include, but are not limited to, any statement preceded, followed by, or including words such as “target”, “believe”, “expect”, “aim”, “intend”, ” can”, “anticipate”, “estimate”. , “”plan”, “project”, “will”, “may have”, “probable”, “should”, “could”, “might”, and other words and terms of similar meaning or their negative. forward-looking statements are subject to inherent risks and uncertainties beyond the control of the Company that could cause the actual results or performance of the Company to be materially different from the expected results or performance expressed or implied by such forward-looking statements.