Galecto Completes Enrollment in Global Phase 2b GALACTIC-1 Trial of GB0139 for the Treatment of IPF
GB0139 is Galecto’s proprietary inhaled once-daily small molecule galectin-3 inhibitor
GALACTIC-1 trial on track to deliver top-line results in mid-2023
IPF is a life-threatening, rapidly progressing and irreversible disease causing scarring of the lungs and significantly impairing lung function. IPF affects approximately 100,000 people in
“We are very excited to complete enrollment in this Phase 2b trial in IPF and are encouraged by the support of the clinical investigators and patients participating in the trial. Limited treatment options for patients with IPF make it an area of significant unmet need and patients would benefit from innovative and disease-modifying treatment options that are safe and well-tolerated,” said Dr. Hans Schambye, President and Chief Executive Officer of
GALACTIC-1 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2b study being conducted across approximately 100 centers globally. The study is designed to investigate the safety and efficacy of Galecto’s most advanced compound, GB0139, in 141 patients with IPF. Patients in GALACTIC-1 are randomized (2:1) to either receive GB0139 or placebo. Patients in the GB0139 group receive a 3mg dose of GB0139 once daily for 52 weeks. The primary endpoint of the trial is to assess the annual rate of decline in forced vital capacity (FVC). Reduction in the decline of FVC was accepted by the
GB0139 is an inhaled small molecule inhibitor of galectin-3 that is administered as a once-daily inhalation via a generic dry powder inhaler. GB0139 is designed to specifically target galectin-3, a main regulator of the fibrosis cascade. The overexpression of galectin-3 is ubiquitous in fibrotic tissue, including fibrotic lung tissue, and is linked to both disease severity and disease progression, as well as acute exacerbations of IPF.
In clinical trials completed to date, inhaled GB0139 was found to be generally well-tolerated, and inhibited galectin-3 in the lungs in a dose-dependent manner. GB0139 was observed to decrease a range of plasma biomarker levels, such as YKL-40 and platelet-derived growth factor (PDGF), that have been linked to mortality, disease severity and disease progression in IPF.
There are currently no approved therapeutics that specifically target galectin-3. GB0139 for the treatment of IPF has been granted Orphan Drug Designation by both
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the potential tolerability and efficacy of GB0139; the primary endpoint of the GALACTIC-1 trial being accepted by the FDA; that GB0139 may become an important addition to the therapeutic arsenal in the treatment of IPF, the timing of top-line results from the GALACTIC-1 trial, as well as Galecto’s general focus and plans for clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements,
For more information, contact:
|Hans Schambye, CEO
|+45 70 70 52 10|
|+1 617 430 7577
||+41 78 680 0538|
Source: Galecto, Inc.