Galecto’s GB0139 Shows Favorable Safety and Tolerability Profile with Promising Changes in Efficacy Markers in Hospitalized COVID-19 Patients
- GB0139 significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulation
- Data demonstrate potential of GB0139 in patients with viral-induced acute lung injury
Galectowill prioritize resources for its four phase 2 trials in fibrosis and cancer
GB0139, dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days, showed a favorable safety profile with no treatment-related serious adverse events reported. GB0139 had a positive trend on acute lung injury related to COVID-19, as patients who received GB0139 showed signs of improved lung function with a significant decline in oxygen flow requirements compared to patients only receiving standard of care (SOC), which included dexamethasone, remdesivir and anticoagulant therapy.
GB0139 showed target engagement by reducing galectin-3 levels compared to SOC (p < 0.01). Patients with COVID-19 were able to inhale GB0139 and achieve consistent exposure of GB0139 at levels previously associated with systemic biomarker responses in IPF patients (including YKL-40 and PAI-1). Patients showed improved inflammation and coagulation biomarkers, including CXCL10, thrombocytes and reduced D-dimers, as well as improved biomarkers of liver function and tissue damage. While the severity of the disease at baseline was worse in patients receiving GB0139, these patients had similar outcomes to patients receiving only SOC.
In a post-hoc subgroup analysis of patients with moderate to severe COVID-19 infection, there was a 21% reduction in mortality in patients treated with GB0139 vs SOC. Furthermore, patients had reductions in CXCL10, IL-6, IL-10 and TNFα, suggesting that GB0139 has the potential to counter the cytokine storm and prevent acute respiratory distress syndrome and multi-organ failure. GB0139 also reduced PAI-1 and YKL-40 levels – as previously observed in Galecto’s phase 2a trial in IPF patients. These markers are associated with a high risk of thrombosis and fibrosis, suggesting that GB0139 may reduce lung fibrosis seen in COVID-19 patients. This data together suggests GB0139 could result in clinical improvement in moderate to severe COVID-19 patients by reducing inflammation, improving lung and other organ function and reducing the risk of cytokine storm and micro-thrombosis.
Dr. Hans Schambye, President and Chief Executive Officer of
It is anticipated that additional data from this trial will be released at a scientific conference later in 2021.
In this open-label trial (https://clinicaltrials.gov/ct2/show/NCT04473053), 41 patients were randomized to receive either standard of care or inhaled GB0139 (dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days) plus standard of care, to evaluate the safety and tolerability of GB0139, pharmacokinetics, and its effects on clinical outcomes and biomarkers.
GB0139 is the world’s first small molecule galectin-3 inhibitor studied in man. The compound is not taken up via the oral route and is being developed as an inhaled therapeutic in Idiopathic Pulmonary Fibrosis (https://clinicaltrials.gov/ct2/show/NCT03832946). Early phase studies have shown that inhalation of GB0139 in healthy volunteers and in IPF patients is well tolerated, and the phase 2a IPF study showed significant effects on several biomarkers linked to worse outcomes in IPF.
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 tolerability and efficacy of GB0139 in COVID-19 lung inflammation; the potential of galectin-3 inhibition in patients with acute lung injury; that GB0139 may reduce lung fibrosis seen in COVID-19 patients; that GB0139 has the potential to counter the cytokine storm and prevent acute respiratory distress syndrome and multi-organ failure; and Galecto’s 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|
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Source: Galecto, Inc.