Galecto Inc GLTO announced topline results from its Phase 2b GALACTIC-1 trial evaluating the safety and efficacy of inhaled GB0139 for idiopathic pulmonary fibrosis (IPF).
The GALACTIC-1 trial did not meet its primary endpoint of change from baseline in the rate of decline in forced vital capacity (FVC).
Galecto plans to discontinue the development of GB0139.
Going forward, Galecto will focus on development opportunities for severe liver diseases.
The GALACTIC-1 trial 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 over 52 weeks.
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.
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.
Galecto plans to initiate Phase 2a GULLIVER-3 trial evaluating GB1211 in patients with decompensated NASH cirrhosis, which will evaluate efficacy and tolerability at additional dose levels. The trial is expected to be initiated in early 2024, subject to obtaining additional financing.
Price Action: GLTO shares are down 57.30% at $1.00 on the last check Tuesday.
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