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.
Dr. Hans Schambye, President and Chief Executive Officer of
The GALACTIC-1 trial is a Phase 2b, 52-week randomized, double-blind, multicenter, parallel, placebo-controlled trial investigating the safety and efficacy of GB0139 (3mg) in patients with IPF, with the rate of decline of forced vital capacity (FVC) as the primary endpoint. Based on blinded FVC (lung function) data from patients in this trial, the Company has determined that it may be possible to demonstrate a meaningful effect with fewer than the planned target of up to 210 randomized patients. As a result of this statistical analysis, the Company plans to seek regulatory approval of a protocol amendment to reduce the target patient population for the GALACTIC-1 trial, which would enable
The research article is titled “GB0139, an inhaled small molecule inhibitor of galectin-3, in COVID-19 pneumonitis: A randomised, controlled, open-label, Phase 2a experimental medicine trial of the safety, pharmacokinetics, and potential therapeutic value.” It is available through the medRxiv preprint server and has not yet been peer-reviewed.
In this open-label trial (https://clinicaltrials.gov/ct2/show/NCT04473053), 41 patients were randomized to receive either standard of care, which included treatments such as steroids, heparin, remdesivir and tocilizumab (n=21), 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 (n=20), to evaluate the safety and tolerability of GB0139, pharmacokinetics, and its effects on clinical outcomes and biomarkers. Patients had a mean age of 65 years, mean BMI of 32, multiple comorbidities, and were hospitalized and needed oxygen therapy, but did not require mechanical ventilation.
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; that GB0139 may reduce lung fibrosis seen in COVID-19 patients; that GB0139 has the potential to counter the cytokine storm, inflammation-associated thrombosis, short and long-term fibrosis and multi-organ damage; the GALACTIC-1 trial, including plans for continuing to enroll patients and working with regulatory authorities to amend the protocol for the trial; that
For more information, contact:
Hans Schambye, CEO
Jon Freve, CFO
+45 70 70 52 10
Ashley R. Robinson
+1 617 430 7577
Sandya von der Weid
+41 78 680 0538