Galecto, Inc. announced topline results from its Phase 2b GALACTIC-1 trial evaluating the safety and efficacy of inhaled GB0139 for the treatment of idiopathic pulmonary fibrosis (IPF). The GALACTIC-1 trial did not meet its primary endpoint of change from baseline in rate of decline in forced vital capacity (FVC). Based on the results of the GALACTIC-1 trial, Galecto plans to discontinue development of GB0139.

Going forward, Galecto will focus on development opportunities for the treatment of severe liver diseases. The GALACTIC-1 trial (NCT03832946) enrolled 173 patients who were not receiving pirfenidone or nintedanib, the current standard of care for IPF. The trial compared treatment with the inhaled 3 mg dose of GB0139 to placebo (randomized 2:1) over 52 weeks.

The GALACTIC-1 trial did not meet its primary endpoint of change from baseline in rate of decline in forced vital capacity (FVC) at week 52. Levels of galectin-3 increased from day 0 to week 52 in both the placebo and active GB0139 3 mg arms, and thus there was no confirmation of target engagement in the trial. The mean change in FVC from baseline to week 52 was -316.6 ml in the GB0139 3 mg arm compared to -127.4 ml in the placebo arm (placebo-corrected difference of -189.2 ml; 95% CI -311.28 to -67.10 ml).

The observed decrease in lung function in the placebo group was lower than similar placebo groups reported in previous IPF trials with other drugs. In the safety analysis, Galecto observed a significant amount of IPF-like treatment-emergent adverse events in the active GB0139 arm commensurate with FVC development. The most common adverse events included cough, dyspnea and COVID-19.

Treatment-emergent serious adverse events, which included worsening of IPF, were observed in 7.8% of patients in the GB0139 group and 1.4% of patients in the placebo group. Adverse events leading to death were similar in both groups. Galecto intends to work in close collaboration with external experts to analyze the results observed in the placebo arm of the GALACTIC-1 trial.

Additionally, Galecto plans to communicate the results of the GALACTIC-1 trial at an upcoming medical conference. Galecto previously announced that it had concluded a U.S. Food and Drug Administration (FDA) Type C meeting centered around the continued development of GB1211, Galecto?s oral galectin-3 inhibitor product candidate for the treatment of compensated and decompensated cirrhosis. As a result of this meeting and in accordance with guidance received from the FDA, Galecto?s next step in the development of GB1211 is to initiate a long-term, randomized, placebo-controlled, Phase 2a trial in patients with decompensated NASH cirrhosis, which will evaluate efficacy and tolerability at additional dose levels.

This trial, referred to as the GULLIVER-3 trial, is expected to be initiated in early 2024, subject to obtaining additional financing. Galectin-3 and LOXL2 have been shown to be critical drivers of fibrotic disease pathogenesis and are associated with severe liver disease and poor outcomes. Galecto previously announced topline results from its Phase 1b/2a GULLIVER-2 trial of GB1211, its orally available galectin-3 inhibitor, for the treatment of decompensated cirrhosis.

Topline results from the GULLIVER-2 trial showed statistically significant reductions in liver enzymes (AST, ALT and GGT) and other positive biomarker effects after 12 weeks of treatment, as well as a reduction in MELD score. GB1211 also exhibited a favorable tolerability profile in this trial.