Galecto’s oral small molecule galectin-3 inhibitor, GB1211, was well tolerated in pre-clinical and Phase 1 studies and is ready to start a Phase 2a clinical study to treat liver fibrosis in Non-Alcoholic SteatoHepatitis (NASH).
GB1211 has been shown to be effective in several pre-clinical fibrosis models, without any signs of toxicity. Galectin-3 plays a key role in fibrosis development through cellular activation and production of collagen. Inhibiting galectin-3 has been shown to dramatically reduce fibrosis in multiple models of fibrosis in several organs, including the liver.
We believe GB1211 has the potential to significantly improve the lives of patients with liver fibrosis related to NASH and a wide range of other fibrotic diseases. NASH alone represents a significant unmet medical need that is not addressed by the vast majority of compounds in development. GB1211 builds on our experience in developing GB0139, an inhaled galectin-3 inhibitor that targets fibrosis in the lungs, which is currently in a Phase 2b study of 450 patients with idiopathic pulmonary fibrosis,” says Hans Schambye, CEO of Galecto.
Phase 2a study in Q4 2020
Galecto will initiate the Phase 2a study in Q4 2020 in patients with NASH to assess the effect of GB1211 on fibrosis-related biomarkers and other fibrosis endpoints. The liver fibrosis study is the first proof of concept study with GB1211, the only oral galectin-3 inhibitor in development. As such, this study may pave the way for galectin-3 inhibitor based anti-fibrotic therapy in a range of other fibrotic diseases, including liver cirrhosis.