Galecto has announced that the Phase 2b GALACTIC-1 of its GB0139 inhaled galectin-3 inhibitor for the treatment of idiopathic pulmonary fibrosis failed to meet its primary endpoint and, as a result, the company will discontinue development of the DPI. GALACTIC-1 was initiated in February 2019. In March 2021, Galecto announced that it was discontinuing the higher dose arm of the study and would exclude certain patients from the lower dose arm based on recommendations from the Data and Safety Monitoring Board.
According to Galecto, in addition to failing to meet its primary endpoint of change in the rate of decline in FVC at 52 weeks, GALACTIC-1 demonstrated that galectin-3 levels increased in the active arm as well as in the placebo arm over that period. Serious adverse events, including worsening of IPF symptoms, were also more than 5 times higher in the active arm compared to the placebo arm.
Galecto President and CEO Hans Schambye commented, “We are very disappointed that the GALACTIC-1 results do not support the continued development of GB0139 as a new treatment for IPF. Galecto expresses its sincere thanks to the patients and clinical trial investigators for their participation in this study.”
Read the Galecto press release.
