- The Independent Data Safety and Monitoring Board (DSMB) has recommended that the trial proceed as planned without modifications.
- MaaT033 has shown to have an acceptable safety profile and was well tolerated in patients treated for blood cancers and receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT).
LYON, France--(BUSINESS WIRE)-- Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today announced that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS, the largest one to date for a microbiome therapy in oncology, and recommended continuation of the trial without modification. The trial is an international, multi-center, randomized, double-blind, testing MaaT033, an oral freeze-dried formulation against placebo, set to be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients (NCT05762211).
The DSMB, composed of 5 independent experts, reviewed safety data on the first 20 patients (cutoff date as of April 30th, 2024) and concluded that safety was acceptable and well tolerated. Since its first clinical entry in 2020, MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a patented “pooling” process, has continuously displayed a good safety profile.
“The positive outcome of this first DSMB review of the PHOEBUS study significantly builds on the favorable safety and tolerability profile exhibited by MaaT033,” said Gianfranco Pittari, M.D., PhD, Chief Medical Officer of MaaT Pharma. “We are very enthusiastic about MaaT033’s potential to ensure an optimal microbiome ecosystem and enhance clinical outcomes in patients undergoing allogeneic stem cell transplantation.”
“MaaT033 is designed for ambulatory use and chronic treatment; it will address a substantial market of approximately 11,000 patients annually, and with its freeze-dried capsule formulation it will significantly drive our growth,” highlighted Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. “With the GMP manufacturing facility at full capacity, we will produce up to 1,300,000 capsules annually, meeting patient demand and supporting our innovative microbiome therapies.”
About MaaT Pharma
MaaT Pharma, 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, MaaT Pharma launched, in March 2022, an open-label, single arm, phase 3 clinical trial in patients with acute GvHD (aGvHD), following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s 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. MaaT Pharma 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. MaaT Pharma is listed on Euronext Paris (ticker: MAAT).
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).
Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” 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 be materially different from the expected results or performance expressed or implied by such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240702248745/en/
Contacts
MaaT Pharma – Investor Relations
Guilhaume DEBROAS, Ph.D.
Head of Investor Relations
+33 6 16 48 92 50
invest@maat-pharma.com
MaaT Pharma – Media Relations
Pauline RICHAUD
Senior PR & Corporate Communications Manager
+33 6 14 06 45 92
media@maat-pharma.com
Trophic Communications
Jacob VERGHESE or
Desmond JAMES
+49 151 7441 6179
maat@trophic.eu
Source: MaaT Pharma
View this news release online at:
http://www.businesswire.com/news/home/20240702248745/en
