Agomab’s ALK5 inhibitor has proven its ability to target the correct part of the intestine in a phase 2 trial of fibrostenosing Crohn’s disease.
The STENOVA study saw 90 patients with the condition receive one of two doses of the therapy, dubbed AGMB-129, or placebo for 12 weeks on top of standard of care. An interim readout has shown the study hit its primary endpoints of showing that AGMB-129 was safe and well tolerated, Agomab said in a March. 10 release.
The trial also hit its secondary endpoints, which included showing changes in mRNA gene expression in biopsies of the ileum, part of the small intestine that can be constricted as a part of fibrostenosing Crohn's disease. In addition, the study hit its pharmacokinetics endpoints as measured in the amount of metabolites in plasma.
Agomab is holding onto the interim data until a future conference, the Belgian biotech said, with full results from the study then expected in the fourth quarter.
“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,” Agomab’s Chief Medical Officer Philippe West said.
The study was financed by a $100 million series C that the Antwerp, Belgium-based biotech hauled in back in October 2023.
Agomab launched in 2019 to take forward the work of Paolo Michieli, Ph.D., who has researched hepatocyte growth factor (HGF) at the University of Torino for more than two decades. HGF plays a role in cell functions such as proliferation, survival and differentiation and can promote wound healing and tissue regeneration.
In 2021, Agomab bought Origo Biopharma, adding small-molecule drug candidates that target the transforming growth factor beta, including AGMB-129. The company’s hopes are that AGMB-129 can be used in combination with other Crohn’s drugs to help tamp down the disease and stop the scarring in those with fibrostenotic disease.
This could be a sizable market—around 800,000 people are estimated to have Crohn’s in the U.S., around half of whom will be impacted by the fibrostenotic form.