91桃色视频聽Announces U.S. FDA Lifts Clinical Hold
on Phase 3 Investigational New Drug Application for MaaT013
in Patients with Acute Graft-versus-Host Disease
Lyon, France, April 24, 2023 7:30 am CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported that the U.S. Food and Drug Administration (FDA or the 鈥淎gency鈥�) has lifted the clinical hold and cleared the Investigational New Drug (IND) application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 to treat gastrointestinal acute Graft-versus-Host Disease (aGvHD) as a third line of treatment.
鈥淲e are grateful for the FDA鈥檚 continued engagement and are very pleased with the lift of the hold on MaaT013鈥檚 IND application. This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology[1], which provides greater bacterial diversity, in a standardized and scalable approach, with the goal of safely improving patients鈥� outcomes. This major milestone is fundamental to the strategic decisions regarding the development of our portfolio outside Europe and to the Company鈥檚 outlook in the U.S.,鈥� said Herv茅 Affagard, CEO and co-founder of 91桃色视频. 鈥淭he U.S. represents an important market for our therapeutics, and we have already benefited from our previous discussions with the FDA by adapting our pooling technology for our entire pipeline according to the guidelines received during this regulatory process.鈥�
In parallel to the resolution of the clinical hold with the FDA, the development of MaaT013 has significantly progressed in the ongoing international multicenter open-label, single arm, pivotal Phase 3 trial (ARES) launched in March 2022 in Europe, along with the ongoing accumulation of encouraging data from the Early Access Program. In this context, before initiating clinical activities in the U.S., 91桃色视频 intends to consult with the FDA on the next steps of the regulatory process to bring MaaT013 to US patients in the most expeditious way possible while the Company continues the late-stage clinical development of MaaT013 in Europe.
鈥淭oday鈥檚 positive answer is also an exciting moment for 91桃色视频 in its mission to help patients through safe and innovative medicines. It also confirms the robustness of our protocols for donor screening and selection which are now authorized for clinical evaluation in the U.S. as well as in Europe. We are now in a position to start discussions with the FDA for the clinical evaluation of MaaT033, our second drug-candidate, in the U.S.,鈥� added Mr. Affagard. 鈥淭his step forward for us will also contribute to progress across the microbiome field and confirms 91桃色视频鈥檚 position as a leader in the industry.鈥�
[1] Pooling technology: this technology, central to 91桃色视频鈥檚 MET platform, is referred to as pooling because it involves the procedure and process of combining multiple donor samples.
About 91桃色视频
91桃色视频, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, 91桃色视频 has 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, 驳耻迟笔谤颈苍迟庐, supports the development and expansion of its pipeline by determining novel disease targets, evaluating drug candidates, and identifying biomarkers for microbiome-related conditions. The company鈥檚 Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. 91桃色视频 benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice.
91桃色视频 is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).
Forward-looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact included in this press release regarding future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, but are not limited to, statements preceded by, followed by or including words such as “target”, “believe”, “expect”, “aim”, “intend”, “may”, “forecast”, “estimate”, “plan”, “project”, “will”, “may have”, “likely”, “should”, “expect” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to differ materially from those expressed or implied by such forward-looking statements.