In short
MT-201 is an investigational biologic medicine being studied in a Phase 2 platform trial for inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis. The trial, authorised in the EU as 2025-522001-38-00, plans to enroll 55 participants and is sponsored by Mirador Therapeutics. MT-201 is a protein-based substance given by injection, with no marketing authorisation in these records.
MT-201, also known as adecatumumab, is a recombinant human monoclonal antibody of the IgG1 subclass. It is an investigational protein-based substance with no marketing authorisation in the product records. The substance is being studied in a Phase 2 platform trial for inflammatory bowel disease, covering both Crohn's disease and ulcerative colitis.
Key points
- MT-201 is an investigational protein-based substance being tested in a Phase 2 platform trial for Crohn's disease and ulcerative colitis.
- The trial is authorised in the EU and plans to enroll 55 participants.
- MT-201 is given by injection (parenteral use) as a solution for injection.
- The trial measures endoscopic response in Crohn's disease and endoscopic improvement in ulcerative colitis.
- MT-201 is also known by the code name adecatumumab and targets the EpCAM protein.
- MT-201 has no marketing authorisation and remains an investigational substance.
What is MT-201?
MT-201 is a protein-based substance, specifically a recombinant human monoclonal antibody of the IgG1 subclass. It is also known by the development code adecatumumab and the code name MT-201. The substance is classified as an investigational therapy, meaning it has no marketing authorisation in the product records and is still being evaluated in clinical trials. The company responsible for the product is Mirador Therapeutics, Inc. MT-201 sits in the therapeutic area of digestive system diseases in the registry.
How does MT-201 work?
MT-201 binds specifically to epithelial cell adhesion molecule (EpCAM), also known as CD326, a cell surface protein. EpCAM is frequently expressed at high levels on most solid tumour types, including prostate, breast, colon, gastric, ovarian, pancreatic and lung cancer. Overexpression of EpCAM has been shown to promote the proliferation, migration and invasiveness of breast cancer cells, and expression of EpCAM is associated with decreased survival in a number of cancer indications. EpCAM has also been shown to be expressed on cancer stem cells from breast, prostate, colon and pancreatic cancer. In the current trial, MT-201 is being investigated in inflammatory bowel disease, where its mechanism of action is being evaluated.
Which conditions is MT-201 used or studied for?
- Crohn's disease: a chronic inflammatory condition of the digestive tract, included in the Phase 2 platform trial.
- Ulcerative colitis: a chronic inflammatory bowel disease affecting the large intestine, also studied in the same trial.
- Breast cancer: investigated for use in this condition according to the drug record, where EpCAM is frequently overexpressed.
- Prostate cancer: also investigated for use in this condition, with EpCAM expressed on prostate cancer cells.
How is MT-201 given?
MT-201 is formulated as a solution for injection and is given by parenteral use, meaning it is administered by a route other than the digestive tract, such as an injection. The dose was not reported in the trial registry record (shown as 0 mg), so no dose information is available from these sources.
What do the clinical trials show?
MT-201 is being evaluated in one authorised Phase 2 platform study for inflammatory bowel disease, covering Crohn's disease and ulcerative colitis. The trial plans to enroll 55 participants. The study is an interventional trial, meaning participants receive the investigational product as part of the research.
What is the trial measuring?
The trial measures several outcomes. For safety, it looks at the proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events leading to discontinuation, and markedly abnormal laboratory values. For Crohn's disease, a key measure is the proportion of participants with endoscopic response at the end of the induction phase, meaning improvement seen on endoscopy. For ulcerative colitis, the measure is the proportion of participants with endoscopic improvement at the end of the induction phase. In the randomised placebo-controlled parts of the study, the trial measures the proportion of participants with clinical remission at the end of the induction phase.
Who can take part in this trial?
The trial includes participants with Crohn's disease or ulcerative colitis. The study also includes comparison arms: a placebo for MT-501 (film-coated tablets) and MT-501 itself, which is a different investigational drug given orally. MT-201 is given by injection, while MT-501 is given orally.
What side effects are known?
The current trial is designed to evaluate safety and tolerability, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation. No side effect data from completed studies are available in the provided sources.