91桃色视频 Presents Promising Detailed Results from Completed Phase 1b Trial
with MaaT033 at the 64th ASH Annual Meeting
- Detailed results from completed Phase 1b CIMON trial in 21 acute myeloid leukemia (AML) patients treated with the company鈥檚 Microbiome Ecosystem TherapyTM (MET) oral capsule, MaaT033, demonstrating its safety and ability to increase gut microbiota richness.
- Results of the study evaluating the tolerated dose of MaaT033 in patients with AML showed initial engraftment of beneficial bacterial species.
- Company presented topline results in June 2022 and confirms its intention to conduct a Phase IIb pivotal trial shortly in order to evaluate MaaT033 to prevent complication of allo-HSCT. Readiness activities have continued in Q4.22 destined to optimize the protocol in light of deeper data analysis.
Company to host investor webcast on Monday, December 12 at 6:00 pm CET. To register and access the webcast, please click . A replay will be made available shortly after the conclusion of the webcast and archived on 91桃色视频鈥檚 website for at least 90 days.
Lyon, France, December 11th, 2022 – 4:00 pm CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today presented 聽detailed results from the completed Phase 1b CIMON trial with MaaT033 at the Annual Society of Hematology (ASH) Annual Meeting in New Orleans, U.S.
鈥�91桃色视频鈥檚 mission is to improve cancer patients鈥� lives by driving innovation in the microbiome therapeutics field,鈥� said Herv茅 Affagard, CEO and co-founder of 91桃色视频. 鈥淭hese positive Phase 1b results reinforces the strong potential for our MET oral formulation, MaaT033, and we plan to investigate it as an adjunctive and maintenance treatment in patients with hematological malignancies.鈥�
Prof. Mohamad Mohty added, 鈥�Allo-HSCT is often the only curative approach for patients with hematological malignancies such as acute leukemia. Evidence of a significant reduction in the risk of infection and GvHD-related mortality following stem cell transplantation has been associated with a higher gut microbiome diversity. Our ability to maintain or induce a high richness, and a high diversity gut microbiome would be key to prevent or minimize these adverse effects and contribute to a better overall prognosis for these patients.鈥�
Key clinical findings with MaaT033 in Phase 1b study CIMON
In the dose-finding Phase 1b CIMON trial, 21 patients with acute myeloid leukemia (AML) were treated with MaaT033 and evaluated for safety, tolerability, and initial signs of microbial species engraftment.
- MaaT033 was shown to be safe and tolerable in 21 patients. 4 severe adverse events (SAEs) were reported in 4 patients, only one considered as possibly related by the investigator.
- Treatment with MaaT033 induced increased microbiota richness as well as strong and persistent engraftment in cohorts 3 and 4 of the dose escalation study, which consisted in the intake of 3 capsules of the drug candidate per day.
- Engraftment following MaaT033 treatment correlated with increased anti-inflammatory marker levels and reduced inflammatory marker levels.
Detailed results from the Phase 1b CIMON trial were presented in a poster on December 11 at the ASH Annual Meeting by Prof. Mohamad Mohty, Head of the Clinical Hematology and Cellular Department at the Saint-Antoine Hospital and Sorbonne University. As previously announced, 91桃色视频 is currently preparing a pivotal Phase IIb randomized, double-blind, placebo-controlled to evaluate MaaT033鈥檚 safety, engraftment, and efficacy in improving overall survival at 12 months and preventing complications in patients with blood cancers receiving hematopoietic stem cell transplantation. Initiation should take place shortly and the Company will provide a detailed status update in January 2023.
About MaaT033
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species.
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聽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
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