Galecto has announced that the company’s Phase 2b GALACTIC-1 study of GB0139 (formerly TD139) galectin-3 inhibitor DPI for the treatment of idiopathic pulmonary fibrosis (IPF) will discontinue the higher dose (10 mg) arm and will limit enrollment in the lower dose (3 mg) arm to patients who are not taking nintedanib or pirfenidone. The company said that it is making the changes based on recommendations from the Data and Safety Monitoring Board. According to Galecto, “The DSMB informed the company, based on unblinded safety and efficacy data, that there was an imbalance in the serious adverse experiences across the study groups, but not an imbalance between the groups in mortality.”
The 52-week trial was initiated in February 2019, and was expected to enroll 450 IPF patients who would receive either 10 mg of GB0139, 3 mg of GB0139, or placebo. Now Galecto says that all patients recruited from here out will be randomized to receive either the 3 mg dose or placebo. Enrollment is expected to be completed in 2021, and data from the trial are expected to be available in 2022.
Galecto CEO Hans Schambye commented, “Galecto is committed to patient safety and continuing the development of life changing treatments for patients with IPF. Around 50% of IPF patients in Europe and the US do not receive treatment with either pirfenidone or nintedanib, representing a very significant unmet medical need, as they have no available treatment options. Based on our prior phase 1b/2a study of GB0139 in IPF patients, we believe the 3 mg dose has the potential to be an effective clinical dose for these patients. There is a very strong demand for a tolerable alternative to the approved therapies.”
In September 2020, the company announced that it had raised $64 million to support continued development of GB0139 and other candidates, and Schambye said that development of its oral galectin-3 inhibitor is expected to be unaffected by the issues with the GALACTIC-1 trial “which relate solely to the inhaled GB0139 in IPF.”
Read the Galecto press release.
