Drugs / MaaT033
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 2 met primary | ||||||
| Phase 1 | NCT05889572 | Jun 2023 → Jul 2024 | amyotrophic lateral sclerosis | MaaT Pharma | Completed | Met primary |
| Phase 1 | NCT04150393 | Oct 2020 → Dec 2021 | chemotherapy-induced toxicity, hematologic disorder | MaaT Pharma | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07001618 | Nov 2025 → Sep 2030 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05654753 | Mar 2024 → Sep 2027 expected | spondyloarthropathy | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-10-07 | MaaT Pharma | Results MaaT Pharma Announces Positive Second Safety Interim Analysis from DSMB for Phase 2b PHOEBUS Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT maatpharma.com ↗
The DSMB conducted an unblinded safety review of data from the first 120 enrolled patients and identified no safety concerns and no excessive mortality related to MaaT033 as of today. |
| 2025-05-12 | MaaT Pharma | Results MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS) maatpharma.com ↗
MaaT033 demonstrated a favorable safety and tolerability profile, supported by biomarker and microbiome analyses. |
| 2025-04-08 | MaaT Pharma | Results MaaT Pharma Announces Positive Safety Interim Analysis from DSMB for Phase 2b Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT maatpharma.com ↗
Following a milestone unblinded interim safety review, the independent Data Safety Monitoring Board (DSMB) has recommended that the study proceed without modification. |
| 2025-01-21 | MaaT Pharma | Results MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT maatpharma.com ↗
The routine DSMB, which convenes every six months, is composed of 5 independent experts, reviewed safety data on 59 patients (cutoff date as of October 31 st , 2024) and concluded that MaaT033 is well tolerated and has an acceptable safety profile. |
| 2024-11-26 | MaaT Pharma | Results MaaT Pharma Announces Positive Phase 1b Results, Meeting Primary Endpoint in the Evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS) maatpharma.com ↗
The independent Data Safety and Monitoring Board (DSMB) concluded that MaaT033 showed good safety and tolerability in ALS patients when dosed for two months. |
| 2024-07-02 | MaaT Pharma | Results MaaT Pharma Announces First DSMB Positive Review of Ongoing Phase 2 Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT maatpharma.com ↗
The DSMB, composed of 5 independent experts, reviewed safety data on the first 20 patients (cutoff date as of April 30 th , 2024) and concluded that safety was acceptable and well tolerated. |
| 2024-02-29 | MaaT Pharma | Results MaaT Pharma Announces Positive Review from the DSMB on the Ongoing Phase 1 Clinical Trial Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS) maatpharma.com ↗
More precisely, it should be noted that no serious or severe adverse events were observed, and no infectious events could be related to MaaT033. |
| 2023-09-07 | MaaT Pharma | Regulatory MaaT Pharma Announces European Medicines Agency Granted MaaT033 Orphan Drug Designation Aiming to Improve Overall Survival in Patients Undergoing Hematopoietic Stem Cell transplantation maatpharma.com ↗
MaaT033 (capsule), which is being developed as an adjunctive and maintenance therapy to improve overall survival in allo-HSCT, has received orphan drug designation ( ODD) status from the European Medicines Agency (EMA). |
| 2023-03-27 | MaaT Pharma | Regulatory MaaT Pharma Receives Two Clinical Trial Application Authorizations to Evaluate MaaT033 in Two Therapeutic Indications in Europe maatpharma.com ↗
MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to improving survival outcomes for patients with cancer , announced today that it has received regulatory authorizations for its two clinical trial applications evaluating MaaT033 in hemato-oncology and in amyotrophic lateral sclerosis (ALS). |
| 2022-12-11 | MaaT Pharma | Results MaaT Pharma Presents Promising Detailed Results from Completed Phase 1b Trial with MaaT033 at the 64th ASH Annual Meeting maatpharma.com ↗
Results of the study evaluating the tolerated dose of MaaT033 in patients with AML showed initial engraftment of beneficial bacterial species. |
| 2022-06-02 | MaaT Pharma | Results MaaT Pharma Confirms Positive Results from Completed Phase 1b CIMON Study Evaluating MaaT033 in Blood Cancer Patients maatpharma.com ↗
The topline results also show rapid and persistent engraftment of MaaT033 in the patients’ gut. |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MaaT033 | “MaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product...” NCT05654753 ↗ |
| Action | Restore | “aims to restore gut microbiota” NCT07001618 ↗ |
| Modality | Other / unclassified | “a pooled, allogeneic, lyophilized, and standardized fecal microbiotherapeutic product” PMID 40197991 ↗ Aug 2025 |
| Route | Oral | “formulated as a delayed-release capsule for oral administration” PMID 40197991 ↗ Aug 2025 |