Galecto has concluded subject enrolment in the Phase IIb GALACTIC-1 clinical trial of GB0139 to treat idiopathic pulmonary fibrosis (IPF). The company anticipates topline results from the trial in the middle of next year.
The double-blind, randomised, placebo-controlled, parallel-group, multicentre trial is being carried out at nearly 100 sites across the globe.
It will analyse the safety and efficacy of GB0139 in 141 IPF patients.
The trial subjects will be randomised into a 2:1 ratio to receive either GB0139 or a placebo.
Participants in the GB0139 arm will be given a 3mg once a day dose for 52 weeks.
Evaluating the annual rate of decline in forced vital capacity (FVC) will be the trial’s primary endpoint.
Previously, the US Food and Drug Administration accepted a drop in the FVC decline as the primary endpoint to approve the existing standard of care IPF therapies: Boehringer Ingelheim’s nintedanib and Roche-Genentech’s pirfenidone.
An inhaled small molecule inhibitor of galectin-3, GB0139 is given as a once-daily inhalation through a generic dry powder inhaler.
It is intended to act on galectin-3, which is a key fibrosis cascade regulator.
Galecto chief medical officer Dr Bertil Lindmark said: “The 52-week duration and the centralised read of the primary endpoint forced vital capacity (FVC) makes GALACTIC-1 a significant development for the treatment of IPF.
“If our preclinical data and clinical biomarker data translate to breaking the fall in lung function in IPF, GB0139 may become an important addition to the therapeutic arsenal, in IPF, a disease with cancer-like mortality.”
In priorly concluded trials, inhaled GB0139 was demonstrated to be well-tolerated and hindered galectin-3 in the lungs in a dose-dependent manner.
Furthermore, the treatment lowered a range of plasma biomarker levels, such as YKL-40 and platelet-derived growth factor, associated with mortality, severity and progression of disease in IPF patients.
An irreversible ailment, IPF leads to scarring of the lungs and drastically lowers lung function.