Agomab's ALK5 inhibitor successful in phase 2 Crohn's trial

Agomab, a biotech company based in Antwerp, Belgium, is making promising advancements in the treatment of fibrostenosing Crohn's disease. This condition involves the constriction of the ileum, a part of the small intestine, due to fibrosis. Agomab's ALK5 inhibitor, named AGMB-129, specifically targets this affected region. In a recent phase 2 clinical trial called the STENOVA study, the efficacy of AGMB-129 was put to the test, involving 90 patients who were administered either one of two doses of the drug or a placebo over a 12-week period, in addition to their standard care.

The interim results of the study, released in March, indicate that AGMB-129 successfully met its primary endpoints, demonstrating that the drug is safe and well tolerated. Furthermore, the secondary endpoints were achieved as well, which include significant changes in mRNA gene expression in ileum biopsies. This finding is notable because it confirms the drug’s effect on the part of the small intestine that is typically narrowed by fibrostenosing Crohn’s disease. Additionally, the study also reached its pharmacokinetics endpoints, evidenced by the measurement of metabolites in the plasma.

Agomab plans to present these interim findings at an upcoming scientific conference and anticipates sharing comprehensive results from the trial in the fourth quarter of this year. Philippe West, Agomab’s Chief Medical Officer, highlighted the importance of these interim results, stating they represent a significant milestone for the program.

The STENOVA study was funded by a significant financial boost, namely a $100 million series C funding round that Agomab secured in October 2023. The company was established in 2019, inspired by the work of Dr. Paolo Michieli, who has extensively studied hepatocyte growth factor (HGF) at the University of Torino. HGF is known for its roles in cell proliferation, survival, differentiation, as well as wound healing and tissue regeneration.

In 2021, Agomab expanded its capabilities by acquiring Origo Biopharma, which brought in a portfolio of small-molecule drug candidates targeting the transforming growth factor beta, including AGMB-129. The development of AGMB-129 is part of Agomab's broader strategy to combine it with existing treatments for Crohn's disease. The aim is to mitigate the disease's impact and prevent scarring in patients with the fibrostenotic variant.

This line of research and drug development is particularly significant given the high prevalence of Crohn’s disease, especially in the United States, where approximately 800,000 individuals are affected. Notably, about half of these patients experience the fibrostenotic form of the disease, underscoring the potential market size and impact of successful new therapies like AGMB-129.

Agomab's progress marks an important advance in the ongoing effort to provide more effective treatments for those suffering from Crohn's disease and highlights the potential for novel therapies that address the underlying mechanisms of the disease.