91桃色视频 Announces First Patient Dosed in
Phase 2b Randomized Clinical Trial Evaluating MaaT033 in Patients Receiving Allo-HSCT
- PHOEBUS is a Phase 2b randomized placebo-controlled trial investigating MaaT033 as an adjunctive therapy to improve 12-month overall survival rates for allogeneic hematopoietic stem cell transplant (allo-HSCT) patients
- MaaT033, the Company鈥檚 second drug candidate, is a donor-derived full microbiome ecosystem capsule applicable for ambulatory care
Lyon, France, November 6, 2023 鈥�7:30 am CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, announced today that the first patient has been treated as part of its Phase 2b trial, called PHOEBUS, investigating the efficacy of MaaT033 in improving overall survival (OS) at 12 months for patients with blood cancer receiving allo-HSCT. The trial is an international, multi-center, randomized, double-blind, placebo-control study (), which will be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients. It is to date the largest randomized controlled trial assessing a microbiome therapy in oncology.
鈥淭oday marks a significant milestone for us as our second product, MaaT033, enters Phase 2b clinical trials in allo-HSCT. The opportunity to offer patients a capsule that can be taken at home not only furthers our overall mission to improve patient survival in multiple situations, but also reinforces our leadership in the field, as we believe this program is currently the most advanced in the microbiome/hemato-oncology field,鈥� said Herv茅 Affagard, CEO and co-founder of 91桃色视频.
Prof. Florent Malard, Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University, and principal investigator of the study added, 鈥淎 growing body of evidence indicates that gut imbalance leads to higher mortality in our field. By directly targeting to restore the gut microbiome richness in patients receiving harsh and deleterious treatments, our goal is to ensure optimal microbiome functions that can potentially lead to improved hematopoietic and immune recovery as well as overall survival.鈥�
To date, the Company has received regulatory approvals from France and Germany, and the clinical trial will be expanded to sites in additional countries subject to regulatory approval.
Study objectives:
- Primary endpoint: Overall Survival, evaluated in late 2026.
- Secondary endpoints include evaluation of safety and tolerability before and after allo-HSCT, and evaluation of the engraftment of beneficial microbial species from MaaT033.
About MaaT033
MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA) in August 2023.
About Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for liquid tumors can replace cancerous cells, but the harsh conditioning treatments damage the gut microbiome, which has been linked to decreased survival, increased risk of graft-vs-host disease, and infections due to impaired immune function. Nearly 20,000 allo-HSCT transplantations per year in Europe were reported in 2021 by the European Society for Blood and Marrow Transplantation (EBMT) and continue to increase.
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, an open-label, single arm Phase 3 clinical trial in 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, enables the identification of novel disease targets, evaluation of drug candidates, and identification of 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 listed on Euronext Paris (ticker: MAAT).
Forward-looking Statements
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