Antwerp, Belgium, March 10, 2025 – Agomab Therapeutics NV (‘Agomab’) today announced positive
interim results from 44 patients completing treatment in the ongoing STENOVA1 Phase 2a clinical trial
for AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-β RI or
ALK5) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).
STENOVA is a randomized, double-blind, placebo-controlled study in a total of 90 patients with
symptomatic FSCD. Patients are randomized to receive one of two doses of AGMB-129 or placebo for
12 weeks on top of standard of care, including biologics. The multi-center study is global with
investigational sites in the USA, Canada and Europe. The primary endpoints are the safety and
tolerability of AGMB-129 in FSCD patients. Secondary endpoints include the pharmacokinetics and
target engagement at the site of the ileal strictures as measured through transcriptomics. All primary
and secondary endpoints were met.
The company has also initiated the open-label treatment extension of the STENOVA study with AGM-
B129. Study participants who have completed the double-blind 12-week treatment period are eligible
to participate and can receive treatment for up to an additional 48 weeks.
“The positive interim data for the STENOVA Phase 2a clinical trial represent a significant milestone for
this program, and we look forward to presenting the detailed results at a scientific conference in the
near-term,” said Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics. “We want to thank
all patients and investigators for participating in this trailblazing study, which aims to address the high
unmet medical need that exists in the field of Fibrostenosing Crohn’s disease.”
AGMB-129 is an investigational drug and not approved by any regulatory authority. Its efficacy and
safety have not been established.
About AGMB-129
AGMB-129 is an oral, small molecule GI-restricted inhibitor of ALK5 (or TGF-β RI) currently in clinical
development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-β is a major driver of
fibrosis. AGMB-129 is specifically designed to inhibit ALK5/TGF-β in the GI-tract. Rapid first-pass
metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an
improved safety profile over systemically available inhibitors in this class. In a Phase 1 trial in healthy
subjects, single- and multiple-dose AGMB-129 was generally well-tolerated at all doses tested. In
addition, the trial showed high local exposure to AGMB-129 in the ileum but no clinically relevant
systemic exposure, demonstrating that the GI restricted mechanism may operate efficiently in
humans. Fibrostenosing complications occur in nearly 50% of Crohn’s disease patients and are the
leading cause of bowel resection surgery, however there are no approved specific therapies for FSCD.
AGMB-129 has received U.S. FDA Fast Track Designation.
About Agomab
Agomab is focused on achieving disease modification by modulating inflammation and fibrosis in
chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do
this by targeting biologically validated pathways, including Transforming Growth Factor β, and by
applying specialized capabilities in organ-restricted small molecules. With a differentiated clinical
pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven
track-record and a strong investor base, Agomab is building a transformational company with the aim
to have a real impact on patients.
Contacts
For Agomab Therapeutics
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
Media Requests for Agomab
Dr. Stephanie May
Trophic Communications
E-Mail: agomab@trophic.eu
Phone: +49 171 1855682
