MRM Health’s pipeline includes programs in inflammatory bowel diseases, other inflammatory disorders and immune-oncology, as well as an incubator program in liver diseases and an animal health program as part of a corporate partnership.
STARFISH-UC is a randomized, double-blind, placebo-controlled phase 2b clinical study (NCT07296315)
that received FDA IND Clearance
in
late 2025. The study will enroll approximately 204 patients with mild-to-moderate UC inadequately controlled by 5-aminosalicylic acid
(5-ASA), with or without low-dose steroids, the current standard of care.
It features a 12-week induction phase comparing two MH002 doses against placebo, followed by a 40-week open-label extension. The study
will be conducted at sites throughout Europe and the US. Top-line induction results are anticipated in Q4 2027.
The trial aims to confirm the promising initial efficacy signals such as mucosal healing, anti-inflammatory effects, and clinical
remission along with the favorable safety profile observed after 8 weeks of treatment in prior Phase 2a studies in both UC and the
orphan disease Pouchitis.
Study Contact
Name: Jean-Michel Muhlinghaus, DVM
Phone Number: +32 9 277 08 50
Email: jm.muhlinghaus@mrmhealth.com
Study Contact Backup
Name: Carmen Fleurinck, MD
Phone Number: +32 9 277 08 50
Email: carmen.fleurinck@mrmhealth.com
At this time, MRM Health is not offering expanded access to MH002 and believes that access through MRM Health-sponsored clinical trials remains the most appropriate pathway while safety and efficacy are under evaluation. Information about MRM Health-sponsored clinical trials of MH002 can be found on www.ClinicalTrials.gov by entering the keyword "MH002" into the Intervention/treatment search box. Patients should speak with their treating physician about clinical trial eligibility and other treatment options.
MRM Health may re-evaluate and revise this Expanded Access Policy in the future. Should MRM Health consider making MH002 available through expanded access programs in the future, the Expanded Access Policy will be updated to include procedures for submitting expanded access requests and the criteria that will be used to evaluate such requests.
If you have any questions about this Expanded Access Policy, please contact clinicaltrials@mrmhealth.com.
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