In short
MH002 is an investigational live bacterial product being studied for the treatment of active ulcerative colitis. It is currently in a Phase 2 clinical trial involving 204 participants, testing two different doses against a placebo. The trial is authorised and aims to confirm whether MH002 can reduce inflammation in the colon.
Key points
- MH002 is an investigational bacterial therapy for active ulcerative colitis.
- The trial is in Phase 2 and is currently authorised.
- 204 participants are expected to be enrolled.
- Two doses are being tested: 10,000 million CFU and 40,000 million CFU, taken orally.
- The main measure is the change in the Mayo endoscopic subscore (MES) at 12 weeks.
- This is a placebo-controlled study.
What is MH002?
MH002 is an investigational substance, meaning it is not yet an authorised medicine. It is being developed as a potential treatment for ulcerative colitis, a chronic inflammatory bowel disease. The substance is given orally in capsule form. The trial registry does not provide further details about the exact biological nature of MH002 beyond it being a live bacterial product, as indicated by the dosing unit of million colony forming units (CFU).
How does MH002 work?
The precise mechanism of action of MH002 is not described in the available trial record. The primary outcome is a change in the Mayo endoscopic subscore (MES), which measures how inflamed the lining of the colon looks during an endoscopy. This suggests that the goal of treatment is to reduce visible inflammation in the gut, but the specific biological pathway by which MH002 would achieve this is not stated in the data provided.
Which conditions is it used or studied for?
- Ulcerative Colitis: The only condition for which MH002 is currently being studied. It is being tested in patients with active disease, meaning their condition is currently causing symptoms.
How is MH002 given?
MH002 is administered as an oral capsule. The trial is testing two different strengths of the capsule: one containing 10,000 million CFU and another containing 40,000 million CFU. A placebo capsule that looks the same but contains no active substance is used for comparison.
What do the clinical trials show?
One Phase 2 clinical trial is currently authorised to investigate MH002 in people with active ulcerative colitis. The study plans to enrol 204 participants. The main objective is to confirm the efficacy of MH002 on ulcerative colitis disease activity by measuring the change in the centrally-assessed Mayo endoscopic subscore (MES) from the start of the study to Week 12. This is a measure of how the colon lining looks, assessed by a central team to ensure consistency. The trial is interventional, meaning participants receive a specific treatment and are followed over time.