Unlock stock picks and a broker-level newsfeed that powers Wall Street.
Galecto Publishes Results Showing Safety and Efficacy of the GB0139 Inhaled Galectin-3 Inhibitor in Hospitalized COVID-19 Patients on Standard of Care

In This Article:

Results Support Favorable Safety and Tolerability Profile and Target Engagement of GB0139 and Potential for GB0139 in Severe Lung Disease

Company Provides Update on GALACTIC-1 Trial

BOSTON, Jan. 27, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the publication of the full results of an investigator-initiated open and randomized trial to evaluate Galecto’s inhaled galectin-3 inhibitor, GB0139, in hospitalized patients with COVID-19 infection who required oxygen but not mechanical ventilation, compared to patients only on standard of care.

Galectin-3 plays a key role in COVID-19-related acute lung injury, cytokine storm, T-cell exhaustion and organ micro-thrombosis, and the results from this trial suggest that GB0139 has the potential for treatment of viral induced acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).

The study met its primary endpoint of safety as there were no observed treatment-related adverse events. Despite patients having a mean age of 65 years, mean BMI of 32, multiple comorbidities, and being breathless, all patients were able to effectively inhale GB0139 and achieve pharmacologically relevant plasma levels. Target engagement was confirmed with a statistically significant reduction (p<0.01) in serum galectin-3 levels.

The study showed that GB0139 on top of standard of care (which included treatments such as steroids, heparin, remdesivir and tocilizumab) may rapidly decrease markers of inflammation linked to the cytokine storm, inflammation-associated micro-thrombosis and those of short or long-term fibrosis. Patients treated with GB0139 had a significantly greater rate of decline in oxygen requirement versus standard of care alone and showed other signs of reduced organ damage. These effects were further accentuated in a subgroup of patients with moderate-to-severe disease who were at higher clinical risk. These patients showed multiple signs of improved immune-mediated viral responses as well as decreased lymphocyte exhaustion and decreased level of profibrotic macrophages. A 21% reduction of mortality was observed in this subgroup of patients at high clinical risk.

Professor Bertil Lindmark, Chief Medical Officer of Galecto, stated, “We are excited that the results of this study showed that GB0139 was biologically active and safely administered at high doses (20mg and 10mg) to patients with severe lung disease and difficulties breathing. Galectin-3 inhibition prevents key escalation steps of the viral-induced inflammatory response, including inflammation related thrombosis, and the processes of acute and chronic fibrosis. These novel findings enhance our conviction for the potentially wide medical applicability of our expanding portfolio of galectin-3 inhibitors.”