2020-11-30 08:14:44 GLTO Galecto
11/30/20 11/3008:14 11/30/2008:14 | Galecto announces publication of GB0139 Phase 2a IPF resultsGalecto announced the publication of a paper detailing full results from a phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis in the peer-reviewed publication European Respiratory Journal. The study highlights the effect of inhaled GB0139 in IPF patients on the plasma levels of highly relevant disease biomarkers, in particular YKL-40 and CCL-18, which have been shown to have prognostic significance in IPF. These and several other biomarkers were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo. GB0139, an inhaled small molecule inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, has received Orphan Drug Designation from both the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of IPF. The EMA cited clinically relevant biomarker data, in particular the significant reduction of YKL-40 in IPF patients, as a justification for the ODD designation. GB0139 was shown to be safe and well tolerated in healthy subjects and IPF patients in the phase 2a trial, and dose dependently suppressed expression of galectin-3, a protein known to play a central role in fibrosis in several organs, on alveolar macrophages. Galecto is now investigating GB0139 in the Phase 2b/3 GALACTIC-1 clinical trial in IPF. The trial is a pivotal size, randomized, double-blind, multicenter, parallel, placebo-controlled study across more than 100 centers in the U.S., the EU, and Canada, designed to evaluate the efficacy and safety of GB0139 in 450 subjects with IPF over 52 weeks. |
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