Galecto, Inc. announced results from its phase 2b GALACTIC-1 trial assessing the safety and efficacy of inhaled GB0139 for the treatment of idiopathic pulmonary fibrosis (IPF).
The results did not meet the primary endpoint of a reduced rate of decline from baseline in forced vital capacity.
“Going forward, we are eager to expand our focus on advancing our pipeline of our orally administered compounds, GB1211 and GB2064,” wrote Hans Schambye, president and chief executive officer of Galecto. “We believe that the previously reported promising clinical results with these compounds represent significant and meaningful opportunities in severe liver diseases, including decompensated cirrhosis and hepatocellular carcinoma.”
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IPF is a chronic and progressive rare disease characterized by the buildup of fibrotic tissue in the lung parenchyma. Galectin-3, a profibrotic β-galactoside-binding lectin, is increased in patients with IPF and plays a key role in its pathogenesis.
Read more about IPF therapies
There is currently no cure for IPF. However, 2 antifibrotic drugs, nintedanib and pirfenidone, have been approved by the US Food and Drug Administration (FDA) to slow the disease progression.
The GALACTIC-1 trial included 173 patients with IPF who were not undergoing treatment with nintedanib or pirfenidone. The patients received placebo or 3 mg of inhaled GB0139 over a period of 1 year. The primary endpoint was a change in forced vital capacity at week 52.
The results revealed that levels of galectin-3 were increased in both the treatment and placebo groups, and in the safety analysis, there were significant IPF-like treatment-emergent adverse events, including cough, dyspnea, and COVID-19 in the treatment group. Treatment-emergent serious adverse events occurred in 7.8% of the treatment group and in 1.4% of the placebo group.
Galecto will discontinue development of CB0139 and focus on development of their other oral compounds, GB1211 and GB2064 for the treatment of severe liver diseases.
Reference
Galecto announces topline results from phase 2b GALACTIC-1 trial of GB0139 for the treatment of idiopathic pulmonary fibrosis. News release. Galecto, Inc.; August 15, 2023.
