MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Esme Needham | January 27, 2026 | News story | | FDA, Gastrointestinal tract, MRM Health, ulcerative colitis
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA), allowing MRM to advance MH002 into the phase 2b STARFISH-UC clinical trial in patients with mild-to-moderate ulcerative colitis (UC).
UC is a type of inflammatory bowel disease (IBD) that causes inflammation of the large intestine and is characterised by painful and potentially debilitating symptoms such as fatigue, stomach pain and diarrhoea.
The STARFISH-UC trial will evaluate around 204 patients with mild-to-moderate UC that is inadequately controlled by 5 aminosalicylic acid (5 ASA) with or without low-dose steroids. The trial will take place across Europe and the US, comprising a 12-week, placebo-controlled induction phase and then a 40-week, open-label extension.
A previous phase 2a trial of MH002 in mild-to-moderate UC showed that the drug had a favourable safety profile, as well as anti-inflammatory capacity, recovery of the gut microbiome and other positive effects. MH002 also previously showed promising results in an open-label study for acute pouchitis.
Enrolment in the STARFISH-UC trial is expected to begin in 2026.
“Receiving IND clearance from the FDA is a testament to MH002’s robust clinical foundation and its potential to transform the lives of those living with UC,” said Sam Possemiers, CEO of MRM. “The upcoming STARFISH-UC study is a critical next step in our mission to deliver a convenient, immune system-sparing, one-pill solution for IBD patients.”
MRM is a clinical-stage biotechnology company focused on the development of LBPs for chronic inflammatory diseases.
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