Galecto Announces Topline Results from Phase 2b GALACTIC-1 Trial of GB0139 for the Treatment of Idiopathic Pulmonary Fibrosis

Announces next steps for clinical development plan in severe liver diseases

BOSTON, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology, focused on the development of novel treatments for fibrosis and cancer, today 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.

“We are very disappointed that the GALACTIC-1 results do not support the continued development of GB0139 as a new treatment for IPF,” said Hans Schambye, President and Chief Executive Officer of Galecto. “Galecto expresses its sincere thanks to the patients and clinical trial investigators for their participation in this study.”

Dr. Schambye continued, “As of July 31, 2023, Galecto had approximately $49.0 million in cash, cash equivalents and investments. Given the impact of the results from the GALACTIC-1 trial on our future plans, we are currently evaluating resource allocation with the goal of extending our cash runway into 2025. Going forward, we are eager to expand our focus on advancing our pipeline of our orally administered compounds, GB1211 and GB2064. 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. We plan to provide greater detail and next steps before the end of October.”

GALACTIC-1 Results
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.