News Release Details

• GB1211, a potent oral small molecule galectin-3 inhibitor was well tolerated in human volunteer studies
• Phase 2a study planned to establish the anti-fibrotic effects of GB1211 in grade 2 to 4 Non-Alcoholic SteatoHepatitis (NASH)
• Data presented at the American Chemical Society Meeting, Drug Discovery Chemistry and EFMC-ISMC

Boston, MA/Copenhagen, Denmark, September 15, 2020 – Galecto, Inc., a privately-held biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced today that its  potent and selective 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.

Hans Schambye, CEO of Galecto, said: “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.”

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.

Dr. Fredrik Zetterberg, Galecto’s Director of Medicinal Chemistry, presented data on the studies at the American Chemical Society (ACS) Fall virtual meeting. Dr Zetterberg also presented the data on GB1211 at two other scientific conferences, Drug Discovery Chemistry Virtual and EFMC-ISMC Virtual Event 2020.

About Galecto Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The Company’s pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2a targeting NASH and myelofibrosis. The company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark. Galecto is funded by Novo Holdings, OrbiMed, Ysios, HBM Healthcare Investments, Sunstone Capital, M Ventures, Bristol-Myers Squibb, Maverick Ventures, Seventure and SEED Capital.

Further information can be found at www.galecto.com.

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